Methods for designing a foot orthotic

ABSTRACT

Disclosed are methods and systems for design of a foot orthotic, and a foot orthotic device designed in accord therewith. More specifically described is an individualized foot orthotic device to correct and/or restore the ideal alignment and/or positioning of foot structures. In the method, sequential pressure is applied to regions on a plantar foot surface, and positional information is obtained about each region. Based on the positional information, an orthotic profile is determined, for design of one or more custom, individualized foot orthotic devices for a subject.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. provisional application No.61/011,640, filed Jan. 17, 2008, and to U.S. provisional application No.61/038,020, filed Mar. 19, 2008, both of which are incorporated byreference herein in their entirety.

TECHNICAL FIELD

The subject matter described herein relates to methods for the design ofa foot orthotic and to a foot orthotic designed and prepared accordingto the methods. More particularly, the subject matter is directed tomethods that utilize a digital anatomy of one or more structures in afoot of a patient for the design of one or more custom foot orthotics,to be used, in some embodiments, in a restorative treatment plan.

BACKGROUND

Foot orthotics are typically designed based on an image of the plantarsurface of a patient's foot. Standard foot orthotics attempt to treatfoot or arch pain by providing cushioning. stability or support,sometimes attempting to adjust or stabilize movement about the subtalarjoint. Prior to about 1950, there was little to no standardization inthe methods used to treat mechanically-induced foot pain. A standardizedapproach to the design of foot orthoses was introduced in 1954, whenMerton L. Root, DPM, revolutionized the field with the theory of theSubtalar Neutral Position (STNP) (Lee, 2001, “An Historical Appraisaland Discussion of Root Model as a Clinical System of Approach in thePresent Context of Theoretical Uncertainty,” Clinics in PodiatricMedicine and Surgery, 18(4)).

The subtalar joint is tie joint between the talus and calcaneus bones.Subtalar neutral is where the subtalar joint is neither pronated norsupinated and its importance was based on observations of what Rootsubjectively deemed to be “normal” feet. According to Root's theory,correction of a foot to a “normal” position involves placing of only thesubtalar joint into a ‘neutral’ position, the so-called subtalar neutralposition or STNP. Root's theory involved only correction of the subtalarjoint and did not involve manipulation or correction to other bones orjoints in the foot. Further corrections, postings and wedges were thenadded to an orthotic after the subtalar joint was placed in neutralposition to compensate for any perceived abnormalities. In the presentapplication, the subtalar joint is not a controlling element; rather itis an adaptive joint governed by the position of the joints distal toit. The subtalar joint functions in synergy with other foot structuresto allow the foot to adapt to an infinitely variable topography, withinphysiologic tolerances.

There are two basic types of custom orthoses made today; accommodativeand functional. An accommodative orthosis is typically made from a softor flexible material that cushions and “accommodates” any deformity ofthe foot. This cushioning also results in some dissipation of the forcesrequired for efficient gait that ordinarily would be transmitted up thekinetic chain. In addition to force dissipation, accommodative orthosismade of EVA and similar soft materials are unable to control footmechanics. A functional orthosis is one that controls joint movementsand/or foot position. Because they are rigid, clinicians utilize theseorthoses to hold the foot in a position they deem therapeutic. This isproblematic because the foot must be allowed to continually adapt to theground in order to operate efficiently. For the manufacture of bothtypes of orthoses, the plantar surface of the patient's foot is capturedand its mirror image is produced on the surface of the orthotic devicethat contacts the patient's foot. Materials used to make orthoticdevices designed in accord with Root's theory are typically both strongand rigid, to support the patient's weight in a durable manner, as thefoot cannot bear the weight itself. Such orthotics abnormally maintainthe foot's arch throughout gait, with the orthosis supporting the body'sweight and compressing the soft tissue between the bones and theorthosis. An ideal configuration for an orthotic device that is beyondthe capability of current functional or accommodative orthoses, wouldadjust the bones of the foot to create an internal load-bearingstructure that is self supporting, bears weight on the calcaneus andmetatarsal heads, and enables the foot to adapt to uneven topography.

In practice today, most functional orthotic devices are designed toestablish STNP and maintain it from heel strike to the beginning oftoe-off. Capturing and maintaining STNP is too simplistic an objectiveto apply to the complicated kinematics of the foot with its 33 joints,28 bones, supporting ligaments, tendons, and other structures. UnderRoot's SNTP theory, and other models of foot function such as RotationalEquilibrium Theory, Sagittal Plane Theory, and the Tissue Stress Model,little, if any, consideration is given to correcting the underlyingpathologic changes to foot structure and function. While functional andaccommodative orthotics may temporarily decrease foot pain due torestricting pathologic range of motion and in cushioning the foot, theynecessarily cause pathologic gait, and this approach will inevitablycause pain in other joints in the foot, leg, pelvis and/or back as theycompensate for this abnormal motion. There remains a need for improvedmethods and systems for designing foot orthotics, and for improved footorthotics to correct and/or restore the ideal alignment and/orpositioning of foot structures.

SUMMARY

In a first aspect, a method for determining an orthotic profile isprovided. The method comprises sequentially applying pressure to aseries of localized regions on a plantar surface of a patient's foot,wherein the pressure is sufficient to displace bones of the foot to arestored bone state; obtaining positional information for each of thelocalized regions when the bones are in the restored bone state; anddetermining the orthotic profile based on the positional information.

In one embodiment, sequentially applying pressure comprises applyingpressure across successive lateral bands of the plantar surface. In oneembodiment, pressure is sequentially applied across from 10 to 40 bandswith each band having a width in the range from 0.5 cm to 2 cm.

In another embodiment, applying pressure across a lateral band comprisessimultaneously engaging at least one lateral row of individual pinsagainst the plantar surface.

The pins, in one embodiment, are spaced apart by a distance in the rangefrom 6 mm to 13 mm.

In other embodiments, at least two lateral rows of pins aresimultaneously engaged against the plantar surface. In some embodiments,the at least one row of pins is moved incrementally across the foot inan axial direction to scan the entire plantar surface.

In one embodiment, the individual pins are engaged against the plantarsurface with a common, predetermined pressure. In other embodiments, theindividual pins are engaged against the plantar surface with a series ofdiffering common predetermined pressures.

In one embodiment, obtaining positional information comprisesdetermining the positions of the individual pins. In some embodiments,the orthotic profile is determined directly from the positionalinformation of the individual pins. In still other embodiments,obtaining positional information comprises imaging the plantar surfaceand/or the bone configuration.

In yet another embodiment, determining comprises configuring atherapeutic orthotic profile which compresses tissues sufficiently toraise the bones to their restored state.

In another aspect, a system for obtaining a restored bone profile of afoot is provided. The system comprises a surface for receiving a plantarsurface of the foot; and a pin matrix comprising a plurality ofindividual pins which can be independently raised from the surface toengage the plantar surfaces and compress tissue against bones of thefoot.

In one embodiment, the system comprises a plurality of drivers for thepins, wherein the drivers are coupled to the individual pins to raiseeach individual pin at a known or controlled pressure. In someembodiments, the drivers each comprise a piston driven by a pressuresource. In certain embodiments, a common pressure source is connected toeach of the pistons. In other embodiments, a plurality of pressuresources with at least one pressure source are connected to each piston.

The drivers, in one embodiment, comprise a servo-controlled motoradapted to raise an associated pin by preselected distances. In otherembodiments, the drivers comprise a constant force spring.

In other embodiments, the pin matrix includes from one to four rows ofpins which are configured to span a lateral band of the plantar surface.In one embodiment, the lateral band has a width in the range from 0.5 cmto 2 cm.

In one embodiment, the system further comprises a carriage which holdsthe pin rows, wherein the carriage is mounted to be translated acrossthe surface to sequentially engage the pins against successive lateralbands.

In another embodiment, the system further comprises a plurality ofsensors for determining a penetration depth of each pin as said pin israised upward from the surface. In still another embodiment, the systemfurther comprises a controller connected to the drivers, carriage, andsensors. In various embodiments, the controller is programmed tosequentially position the carriage, raise the pins against the tissue atone or more pressures at each sequential carriage position, and collectthe depth of pin penetration into the tissue at each pressure and eachposition. In another embodiment, the system further comprises sensorsfor determining a penetration pressure of each pin as said pin is raisedupward from the surface, wherein the pressure sensors are connected tothe controller.

In another aspect, methods for design of an orthotic device, in which adigital anatomy of a patient's foot is obtained and analyzed, and arelationship between two or more bones in the foot is evaluated,resulting in the identification of one or more bones for repositioningby the orthotic device, are provided. In one embodiment, one or moretarsal bones is identified for repositioning.

In one embodiment, the digital foot anatomy can be obtained by applyingpressure from a computer-controlled moveable object to the foot, whichcan, in some embodiments, comprise an array of moveable gaugingelements, such as pins. To obtain or analyze the digital anatomy, themethod can involve, in one embodiment, an adjustment to one or morepins. In some embodiments, the moveable pins are arrayed in an offsettriangular grid.

In other embodiments, the method can identify a desired pin position orpin pressure to achieve repositioning of a bone within the foot. In oneembodiment, the bone identified for repositioning is a tarsal bone or ametatarsal bone. The method can comprise fixing the position of thegauging elements for the design of an orthotic device. The method cancomprise designing and/or fabricating the orthotic device based on theadjusted and/or fixed gauging elements.

In some embodiments, the digital anatomy is displayed as an image on acomputer screen. In some embodiments, the displayed image is capable ofbeing manipulated. In some embodiments, the method further comprisesstoring the digital anatomy on a tangible storage medium.

In some embodiments, the method further comprises electronicallytransmitting the digital anatomy. In some embodiments, the methodfurther comprises securing the electronically transmitted digitalanatomy using data compression and/or security encoding.

In another embodiment, analysis of the digital anatomy can define aninitial bone state and a desired restored bone state. The method cancomprise simulation of a movement path for moving a bone from theinitial bone state to the desired restored bone state. The movement pathcan include one or more intermediate states, or a plurality ofintermediate states between the initial and the desired restored bonestates. A movement path can be simulated by superimposition of thedigital anatomies of any two or more states and defining one or moremovements of any bone within six degrees of freedom to move from aninitial bone state to the desired restored bone state, and displaying onthe computer screen. As defined herein, “six degrees of freedom” isdefined to be 3 axes of translation and 3 axes of rotation. The two ormore states can be obtained at different times, such as obtaining adigital anatomy at an initial untreated state as well as obtaining oneor more additional digital anatomies at intermediate state(s) after atreatment.

In another embodiment, the method can comprise setting a timer thatschedules a subsequent obtaining of a digital anatomy or a follow-upappointment. More than one orthotic device can be designed based on theat least one bone state and the desired restored bone state, and theseorthotic device(s) can be labeled to identify sequential order of use,and delivered collectively at one time to a patient or deliveredsequentially individually or sequentially in groups to a patient.

In some embodiments, the method further comprises fabricating theorthotic device using thermal, vacuum or pressure forming.

In some embodiments of the method, analyzing the digital anatomycomprises evaluating the relationship between any two or more of theplantar aspect of the calcaneus, the talus, the cuboid, the navicular,the medial cuneiform, the intermediate cuneiform, the lateral cuneiformand the metatarsal bones.

In some embodiments of the method, the obtaining of the digital anatomycomprises obtaining an image of the foot position by a procedureselected from an MRI scan, a CT scan, an x-ray, ultrasound imaging, orinfrared imaging, or a variation thereof. In another embodiment, theimage of the foot is obtained with the foot in a static, non-dynamicposition; that is, the patient is seated or otherwise stationary.

Also provided in yet another aspect is a treatment plan that compriseswearing an orthotic device designed according to the disclosed methods,and may comprise progressively wearing each of more than one orthoticdevices for a prescribed period of time.

Also provided is a custom orthotic device designed according to thedisclosed methods or using the disclosed systems. The presentlydisclosed custom orthotic device can be used in a treatment plan asdescribed herein.

These and other features of the present teachings are set forth herein.

BRIEF DESCRIPTION OF THE FIGURES

The skilled artisan will understand that the drawings, described below,are for illustration purposes only. The drawings are not intended tolimit the scope of the present teachings in any way.

FIG. 1 is an illustration taken from the prior art showing astress-strain curve of collagen fiber;

FIG. 2 provides an illustration of an offset triangular grid;

FIG. 3A shows a foot platform, and an exploded view of a portion of theplatform, that is a component of a system for use in analysis of apatient's foot and design of an orthotic device;

FIG. 3B shows a surface or computer having a graphical display of apatients foot structure, the computer and its software components of asystem for use in analysis of a patient's foot and design of an orthoticdevice;

FIG. 3C illustrates an embodiment of a pin matrix for use in the system;

FIG. 3D illustrates a pin in an array of moveable pins, and a lockingmechanism to secure the pin in one embodiment;

FIG. 3E depicts a heel rest assembly to assist in positioning a foot ona pin bed to obtain a digital anatomy;

FIGS. 4A-4B provide graphic representations of two views of a digitalanatomy of a foot;

FIGS. 5A-5B provide a graphic representations of two views of digitalanatomy of an abnormal foot;

FIGS. 6A-6F are graphic illustrations of a digital anatomy of anabnormal foot, and the computer-assisted technique for analyzing theimage to design a foot orthotic;

FIG. 7 is a computer-generated image of an x-ray of a foot, with thebones of the lateral cuneiform-navicular-cuboid (LCNC) complex labeled;

FIGS. 8A-8B are graphic representations of two views of digital anatomyof an abnormal foot;

FIGS. 9A-9B are graphic representations in two views of digital anatomyof an abnormal foot;

FIG. 10 is an illustration of a Left-Hand Tensegrity Weave;

FIG. 11 is an illustration of components of an orthotic manufacturingsystem;

FIG. 12 illustrates a LCNC Dynamic Post;

FIG. 13A illustrates an exemplary orthotic device;

FIG. 13B shows a skeleton of a foot placed on an exemplary orthosis;

FIG. 13C shows a side view of an exemplary orthosis with a high lateraltrim line;

FIGS. 14A-14F show various views of a foot orthotic, designed in accordwith the methods described herein, to restore the position of one ormore foot structures in the midfoot region of a right foot; and

FIG. 15 is a block diagram showing some of the components typicallyincorporated in at least some of the computer systems and other devicesperforming the described methods.

DETAILED DESCRIPTION

I. Definitions

As used throughout the present disclosure, the technical and scientificterms used in the descriptions herein will have the meanings commonlyunderstood by one of ordinary skill in the at, unless specificallydefined otherwise. Accordingly, the following terms are intended to havethe following meanings:

As used in this specification and the appended claims, the singularforms “a,” “an,” and “the” include plural referents unless the contextclearly indicates otherwise. Thus, for example, reference to a patient's“foot” can include both feet, reference to an “orthotic device” includesa single device as well as two or more of the same or different devices,and reference to a “tarsal bone” refers to a single tarsal bone as wellas two or more tarsal bones. The use of “or” should be understood tomean “and/or” unless stated otherwise. Similarly, “comprise,”“comprises,” “comprising” “include,” “includes,” “including” “has,”“have” and “having” are interchangeable and not intended to be limiting.It is also to be understood that where descriptions of variousembodiments use the term “comprising,” those skilled in the art wouldunderstand that in some specific instances, an embodiment can bealternatively described using language “consisting essentially of” or“consisting of”.

As used herein, “orthosis” or “orthotic device” refers to a device orappliance to be worn by a subject, in particular a human subject,typically to achieve restoration of optimal joint congruency andphysiologic function to a subject's foot. In some instances, theorthotic device can be worn inside footwear. In some instances, theorthotic device can be worn as footwear or other orthopedic device.

“Congruency” of the joint surfaces of the foot bones refers to thereciprocity of the joint articular surface shapes, sometimes assessed byobserving and/or measuring the joint space volume. An incongruent jointcan be caused, for example, by interposed soft tissue, plasticdeformation of ligaments or gross instability from torn ligaments orfracture. The phrase “relationship between bones in the foot” refers tothe relative positions of bones within a foot and/or their congruency.

The human “kinetic chain” consists of the musculoskeletal andneuromuscular systems that interact to produce maximally efficientmotion under given conditions. The difference between an open and closedkinetic chain is that in an open chain, the body can produce forcegreater than the inertia of the resistance. In a closed kinetic chainthe body cannot produce force greater than the inertia of theresistance, e.g. a leg, loose in space vs. fixed against a hard,immovable surface such as the ground.

As used herein, “digital anatomy” refers to digitized information aboutthe static measurement of the anatomical positions of and relationshipsbetween bones, muscles, tendons, ligaments, fascia, nerves, skin and/orother structures within a foot, and can further encompass associatedkinetic information about a digital physiology and/or digitalpathophysiology, which can be obtained from a foot in a dynamic state,or predicted by a computer system starting from a static measurement ofthe digital anatomy. A digital anatomy is obtained, for example, using afootbed pin sensor array in communication with a computer andappropriate software, or imaging techniques, including but not limitedto magnetic resonance imaging, laser scanning, ultrasound, x-ray, etc.The digital anatomy described herein can be stored in computer-readableform, in a preferred embodiment. The digital anatomy is generallycapable of being represented visually and/or graphically on a computerscreen or video monitor. The digital anatomy can then be analyzed by thecomputer to determine the foot's physiology, that is, its ability toefficiently perform weight bearing and locomotion. This physiology canbe illustrated by animating the body parts in 3D space. or recording aseries of static images in a flipbook video in any one of severalpopular formats, (for example, but not limited to mpg, avi or quicktimevideo). This illustration can be customized for individual patients, andthe digital physiology can be stored and transferred remotely forviewing, education, treatment and/or manufacturing purposes. Once afoot's current condition is determined, i.e., once the staticmeasurement of the anatomical positions of and relationships between oneor more foot structures is determined, an evaluation of the risks fornew pathophysiology of the foot and also up through the kinetic chain tothe back and neck is performed by the computer. The computer willidentify foot pathophysiologies that may lead to pathologic conditionsincluding, but not limited to, heel spurs, acquired flat foot, hip painand idiopathic back pain. This pathophysiology is illustrated byanimating the body parts in 3D space, or recording a flipbook video in apopular format, and such digital pathophysiology can be stored andtransferred remotely for viewing, education, treatment and/ormanufacturing purposes.

“Tarsal bones” refers to the seven foot bones including the calcaneus,talus, cuboid, navicular, medial cuneiform, middle (intermediate)cuneiform and lateral cuneiform bones. “Plantar” refers to the sole ofthe foot, and the phrase “plantar aspect of the calcaneus” refers to theplantar- or sole-facing surface of the calcaneus bone, commonly known asthe heel bone.

“Forefoot” refers to the five metatarsal bones and the phalanges (thetoes). As a point of reference, the first metatarsal bone typicallybears the most weight in the forefoot and plays a role in propulsion.

“Midfoot” refers to five of the seven tarsal bones (the navicular,cuboid, and the three cuneiforms). The distal row of the midfootcontains the three cuneiforms and the cuboid. The proximal row of themidfoot consists of the cuboid and the navicular. The three cuneiformsarticulate proximally with the navicular bone.

“Rearfoot” refers to the talus and the calcaneus. The calcaneus is thelargest tarsal bone, and forms the heel. The talus rests on top of thecalcaneus and forms the subtalar joint, which is the joint below ordistal to the ankle joint.

There are four arches of the foot. The “medial longitudinal arch”includes the calcaneus, talus, navicular, the lateral, middle and medialcuneiforms, and the first three metatarsals. In an ideal foot, themedial longitudinal arch is the highest of the three arches. The“lateral longitudinal arch” includes the calcaneus, cuboid, and thefourth and fifth metatarsals. The lateral longitudinal arch is typicallylower and flatter than the medial arch. The two transverse arches arethe “transverse tarsal arch” (comprising the cuneiforms, the cuboid andthe five metatarsal heads) and the “transverse metatarsalarch”(comprising the 5 metatarsal heads). Some sources say that there isonly one transverse arch which involves only the tarsals.

“First Ray” refers to the navicular, medial cuneiform, first metatarsaland the great toe.

“Lateral Column” refers to the calcaneus bone, cuboid bone and fourthand fifth metatarsals.

“Medial Column” refers to the talus, navicular, middle and medialcuneiforms and first and second metatarsals. Some texts also include thelateral cuneiform and third metatarsal.

“Stress” refers to the force that causes deformation and can act astension, compression or sheer.

“Strain” refers to a measure of the degree of deformation caused bystress.

“Elastic Modulus” refers to the ratio of stress to strain and refers tothe nature of the deformation or stiffness of the material.

“Plastic deformation” refers to the ability of ligaments, tendons andfascia, as tensile structures with specific viscoelastic properties, tobe damaged or to deviate from an ideal, unstressed position. It is apermanent, non-recoverable deformation. These viscoelastic properties,along with the size of the structure, dictate the magnitude of theforces required to produce injury that ranges from microfractures tocatastrophic failure. To permanently damage or tear a ligament or othercollagenous fiber typically requires a force at or above the thresholdat which the structure in question can resist for approximatelyone-third of a second in duration. For example, a cruciate ligament maytear when a football player is hit hard on the side of the knee due tothe brief; but high force of the insult. Alternately, a submaximalstress for more than 20 minutes has been shown to produce permanentstretch of the affected ligaments, known as plastic deformation. Inaddition, microfailure can occur within the range of motion if frequentloading is imposed on an already damaged structure. As another example,a person who works, walks, dances or shops for long periods of time,until his or her feet hurt, can sustain physical and potentiallypermanent damage to ligaments and tendons that can lead to an abnormalgait. As illustrated in the stress-strain curve shown in FIG. 1(Cavanagh, A., Neuromechanics of Human Movement, R. Enoka publishers, p.82, 189, 192-193, 1994), the “toe region” of the graph represents anormal stretch and return elasticity of ligaments and tendons. Here the“curl” in the conformation of the collagen protein molecule ismaintained. In the “elastic region” of the graph, this curl has beenstretched out, but permanent damage does not occur. In other words, atendon/ligament undergoing stress and strain forces within the elasticregion of the graph should fully recover when the load is removed(unless it was already damages in which case repeated loading in thisrange can result in further damage). Hysteresis (energy lost as heatduring the recoil from the stretch) occurs anywhere to the left of thesolid line up to the dotted line which denotes catastrophic failure.Above the “yield point,” irreversible strain occurs.

“Creep” refers to plastic deformation and/or permanent strain in atissue that can occur over time as a result of application andmaintenance of a stress at a set level.

“Pin bed” refers to a bed or box structure having an array of gaugingelements, such as vertically displaceable sensing pins, on which apatient's foot can be placed.

As used herein, “computer-controlled moveable object” can refer to a pinbed, a foot plate, or other surface upon which a plantar surface of apatient's foot is placed for obtaining a digital anatomy or an orthoticprofile. Alternatively, and as will be clear from the context, acomputer-controlled moveable object can also refer to the individualgauging elements, such as a pin in a pin bed.

In the context of the present teachings, “offset triangular grid” refersto an isometric grid formed by arranging gauging elements on thetwo-dimensional planar surface. such as a pin bed, in a regularequilateral triangle pattern. The gauging elements are found at theangle of each equilateral triangle in the grid, as illustrated in FIG.2.

“Display” refers to a computer screen, video monitor, or other devicecapable of presenting an image to a viewer. “Display is capable of beingmanipulated” means that the image can be adjusted, elements added ormoved on the screen or monitor to simulate, predict the effects oft orprescribe various adjustments to image, which in one embodiment can be abone or soft tissue of a foot.

“Electronically transmitting the digital anatomy” refers to the act ofconveying the digitized anatomical information to a receiver or storagedevice, which may reside at a site remote from that at which the digitalanatomy originates. Similarly, digitized anatomical information may besent from a receiver or storage device to a site at which a digitalanatomy can be obtained, and/or to a site at which an orthotic can bemanufactured.

“Data compression” refers to the process of encoding information usingfewer bits (or other information-bearing units) than an unencodedrepresentation would use through use of specific encoding schemes.

“Securing” or “security encoding” refers to the process of encryptinginformation for protection of the digital anatomical information.

“Initial bone state” refers to the relationships of the bones in apatient's foot in a first, unrestored configuration/relationship beforeadjustment or manipulation of the bones, such as by treatment with anorthotic designed in accord with the present methods and systems.“Restored bone state” refers to the configuration/relationship of thefoot bones that is different from an initial bone state, and in apreferred embodiment refers to the configuration/relationship of footbones that is a physiologically or medically desired position.“Intermediate bone state” or “intermediate state” refers toconfiguration/relationship of a patient's foot bones that is between theinitial bone state and a restored bone state.

An image of a foot can be obtained using a means of imaging selectedfrom, for example but not limited to, magnetic resonance imaging (MRI),computed tomography (CT), radiologic imaging such as x-rays, ultrasoundimaging, infrared imaging, or any variations or combinations thereof.

“Superimposition of the digital anatomies” refers to placement of animage or video representing a second digital anatomy on or over a firstimage or video representing a digital anatomy, for comparison of two ormore digital anatomies. In some embodiments, the superimposition of thedigital anatomy images aligns one or more bones in each image. As can beappreciated, superimposition of two images permits assessment ofdifferences between an initial and an intermediate or a restored bonestate, and informs the measurements and/or calculations for design of anorthotic to reposition a foot bone.

“Simulation of a movement path” or “defining one or more movements ofany bone to move from an initial bone state to the desired restored bonestate” refers to the process of measuring or calculating the extent ofmovement of one or more bones needed to reposition the one or more bonesfrom an initial or intermediate bone state at a given time point to anintermediate or restored bone state at a later time. The movements canbe a distance in one or more of the X, Y, Z directions, or can beangular movements around the X, Y, Z axes,

“Six degrees of freedom” or “6DoF” refers to movement in threedimensional space, i.e., the ability to move forward/backward, up/down,left/right (translation in three perpendicular axes) combined withrotation about three perpendicular axes (yaw, pitch, roll). As themovement along each of the three axes is independent of each other andindependent of the rotation about any of these axes, the motion has sixdegrees of freedom. In the context of the present disclosure, 6DoFtypically refers to the movement of one or more bones of the patient'sfoot during repositioning.

“Timer for scheduling a subsequent obtaining of a digital anatomy orfollow-up appointment” refers to a component of the method or system inwhich a desired length of time for treatment with an orthotic isassessed and the next step in treatment, such as an appointment with thetreating clinician or physician to monitor progress or to design a neworthotic, is prescribed.

“Treatment plan” refers to the design of one or more foot orthosis, eachof which is to be worn by a patient to achieve a desired repositioningof a foot bone.

“Labeled in order of use” refers to markings on two or more footorthoses to indicate the sequential order in which the two or moreorthoses are to be worn.

“Progressively wearing” refers to the sequential wearing of two or morefoot orthoses by the patient.

“Saddle” refers to the shape of the orthosis that corresponds to thefoot structures supporting the transverse tarsal arch. In oneembodiment, an ideal saddle is convex in the sagittal plane and concavein the frontal plane, and is slightly higher on the medial side. “Cuboidtriangle post” refers to the foot structures under the metatarsals.FIGS. 13A-13C discussed below illustrate these terms.

“Ameliorating” or “ameliorate” refers to any indicia of success in thetreatment of a pathology or condition, including any objective orsubjective parameter such as abatement, remission or diminishing ofsymptoms or an improvement in a patient's physical or mental well-being.Amelioration of symptoms can be based on objective or subjectiveparameters; including the results of a physical examination and/or apsychological evaluation.

When a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise. between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated or intervening value in a stated range and any otherstated or intervening value in that stated range is encompassed by thedisclosure. The upper and lower limits of the smaller ranges can beindependently included or excluded in the range, and each range whereeither, neither or both limits are included in the smaller ranges isalso encompassed by the disclosure, subject to any specifically excludedlimit in the stated range. Where the stated range includes one or bothof the limits, ranges excluding either or both of those included limitsare also included.

II. Methods for Design of a Foot Orthotic

The section headings used herein are for organizational purposes onlyand are not to be construed as limiting the subject matter described inany way.

The present teachings are directed to methods for diagnosis andevaluation of plastic deformation occurring in the tensile structures ofa patient's foot, and for treatment of such plastic deformation, acustom foot orthotic device designed in accord with methods describedherein.

A. Foot Anatomy

The method described herein for design of an orthotic device andrestoration of a foot structure takes into consideration foot structuresin addition to the subtalar joint. The foot has 28 bones, including thetwo sesamoid bones under the great toe, 33 joints and a large number ofarticular surfaces within the joints, in addition to soft tissues suchas muscles, tendons and ligaments. The methods described herein takeinto consideration that plastic deformity of the ligaments and tendonsallows bones in the midfoot to slip downward. When this happens, thearticular surfaces of the involved bones are no longer congruent. Inmany cases this leads to a rigid midfoot that cannot flex when necessaryand to hypermobile joints in the forefoot and the rearfoot to compensatefor the rigid midfoot. A patient's foot whose midfoot joints areincongruent will further pronate (flatten) under the patient's weight,as without the proper anatomical configuration, the foot musclescontinue to weaken and the tendons/ligaments continue to creep.

This concept is illustrated in FIG. 1. Physiologic changes occur whenviscoelastic structures, such as ligaments and tendons of a foot,undergo stress and strain. A viscoelastic structure placed under anystress that is below the threshold of catastrophic failure yet above alevel of stress where it can return to normal position with no damage,will obtain some degree of plastic deformation. If the same stressescontinue, plastic deformation will continue as well. As the joint spacesof the foot are narrow it takes little plastic deformation of thesupporting ligaments to negatively alter the joint(s) congruency as oncethe ligaments creep, the bones are no longer held securely in place andwill displace according to the forces placed on them such as by theforce of gravity. This eventually results in fixation of the joint(s) astheir surfaces wedge against one another. This wedging effectparticularly occurs with the midfoot tarsal bones and inhibitsphysiologic foot function causing a cascade of abnormal motion thatresult in further plastic deformation, more fixations and damage to thearticular cartilage of the involved joint(s).

As will become apparent from the description of the method herein, anorthotic device designed in accord with the method restores, rather thanmerely supports, the midfoot and any midfoot deformities. Severalembodiments of the present disclosure are described in detailhereinafter. These embodiments can take many different forms and shouldnot be construed as limited to those embodiments explicitly set forthherein. Rather, these embodiments are provided so that this disclosurewill be thorough and complete, and will fully convey the scope of thepresent disclosure to those skilled in the art.

The presently disclosed methods for design of a foot orthotic andrestoration of one or more foot bones is based, at least in part, on anunderstanding of foot anatomy, and, in particular on: (1) an intricatepattern of Internal Tarsal Ligaments (ITL linkages). This chain ofligaments includes ligaments between (i) the cuboid and the lateralcuneiform; (ii) the lateral cuneiform and the middle cuneiform; and(iii) the middle cuneiform and the medial cuneiform, as well as (2) thelateral cuneiform, navicular and cuboid (LCNC) complex. The ITL linkagesplay a role in efficient ambulation and the bones of the LCNC complexfunction in a specific way during stance phase of ambulation. Thesefindings and their role in restoration of foot function will be detailedbelow.

Plastic deformation of the supportive structures in the foot is causedthrough normal wear and tear and through accelerated stresses, such asmodern footwear, hard flat surfaces, distance running, obesity, aging,etc. These conditions cause the midfoot to begin to collapse due to theplastic deformation of its ligaments, tendons and fascia. Two of thesesupportive structures are the long and short plantar ligaments. Strainof these two ligaments allows the calcaneus to plantar flex, at the sametime the medial arch decreases in height causing the head of the firstray to increase its distance from the calcaneus. This results inforefoot abduction and subsequent eversion of the calcaneus, also knownas a pronated foot. As the calcaneus plantar flexes, the calcaneocuboidjoint widens on the plantar aspect. This allows the cuboid toover-rotate when the lateral column bears weight. Over-rotation of thecuboid deforms ITL linkages by preventing the lateral cuneiform frombeing pulled into a notch between the cuboid and the navicular. Aconsequence of these actions is that the medial and lateral columnscannot lock together to form a rigid lever for toe off. As weight movesmedially during gait, ground force reaction on the medial column is notmet with resistance that results in inefficient energy transfer andpathologic gait. Changes to the midfoot at this point can be visible tothe naked eye, and dubbed, in lay terms, a “flat foot”. Over time, thisplastic deformation of the tensile structures in the foot allows themedial column tarsal bones to drop far enough that they become wedgedagainst one another. As the medial column tarsal bones become wedged,the tensile structures in the rearfoot and forefoot must compensate andtherefore undergo plastic deformation. In this case, instead of thebones becoming jammed against one another, they become hypermobile. Theparadoxical result is a rigid midfoot with overall foot hypermobility.In some cases, the lateral column collapses due to strain of the tensilestructures, further keeping the medial and lateral columns from lockingtogether via the lateral cuneiform (as in the ideal LCNC complex). Ifthe cuneiforms fixate but do not collapse, functional halux limitus isobserved, or bunion formation without excessive pronation. When themedial column begins to collapse causing the distance between thecalcaneus and the first metatarsal head to further increase, plantarfasciitis can occurs. In extreme cases, a Charcot deformity secondaryto, for example, trauma to the foot is observed. In these cases, theentire tarsal complex collapses, i.e., the transverse tarsal arch has adecreased height, with patients presenting with flat, forefoot abductedfeet having calcaneal eversion.

While these cases represent a spectrum of presentations possible withmidfoot tensile structure plastic deformation, and they may appear to bevastly different in nature, they have similar causality in the sequenceof events. The calcaneus loses plantar angle, which allows the cuboid toover rotate when the lateral column bears weight. When this happens,neither the ITL, nor LCNC complex can activate correctly, thus themedial and lateral columns cannot act together when needed. Mostly orfully restoring proper anatomical configuration of the midfoot tarsalbones and dynamically (i.e. while moving through a range of motion)supporting them in the proper configuration will ameliorate pathologiesin gait, and largely or fully re-establish a physiologic gait that iscloser to optimal for that individual. From the perspective that thehuman body is a tensegrity structure—that is, a self-stabilizingstructure where tension is continuous and compression isdiscontinuous—an objective in one embodiment is to realign thecompressive units (the bones) so that the tensile units (ligaments,tendons, muscles) may contract or extend to produce a desired tension inorder to maintain the tensegrity structure and maximize the forcetransfer through the kinetic chain.

B. Methods and Systems for Design of an Orthosis

Provided herein in one embodiment, is a method to evaluate a patientsfoot and to design an orthotic device that restores optimal desiredanatomical configuration of midfoot tarsal bones, and dynamicallysupports the midfoot tarsal bones in a configuration that re-establishesa desired physiologic gait, e.g., a gait that alleviates a symptomsuggestive of deformation in a foot anatomical configuration. A systemfor design of the orthotic device in accord with the method is alsoprovided. The method and the system are now to be described withreference to FIGS. 3-10.

In the method, a patient experiencing foot pain or another symptomsuggestive of a deformation in a foot anatomical configuration isprovided. A digital anatomy or orthotic profile of the patient's toot(or feet) is obtained, and the digital anatomy is analyzed to evaluate arelationship between two or more bones in the foot. Based on theanalysis, one or more tarsal bones are identified for repositioning torestore a desired anatomical configuration to the foot by one or moreorthotic devices.

In one embodiment, the system for application of the method is comprisedof a pin matrix comprising a plurality of moveable pins, the pinsmoveable for contact with a plantar surface of a foot placed above or onthe matrix. In some embodiments, a display in the system is capable ofdisplaying a digital anatomy of the foot, based on positionalinformation of the pins' interaction with the foot. In a preferredembodiment, a computer program in the system analyzes the digitalanatomy and evaluates a relationship between two or more bones in thefoot, and determines an adjustment to one or more pins in the pin bed toachieve a corresponding adjustment to one or more foot bones. In someembodiments, the adjustments are made to midfoot tarsal bones.

The system has robust measurement, analytical, diagnostic and adjustmentcapabilities for designing and optionally making custom orthotics. Thesystem measures, analyzes and diagnoses, and adjusts the bones andtensile tissues (ligaments, tendons and fascia) in a patient's foot. Thesystem has the capabilities for mapping a foot surface topography and/ormeasuring pressure points on the foot plantar surface, and additionallyhas the ability to generate a digital anatomy of a foot. Such a digitalanatomy of the foot includes: (1) the shape and position of the plantarsurface of the tarsal and/or metatarsal bones of the foot, (2) acomputer generated three-dimensional representation of the shape andposition of the bones within the foot, (3) the ability to determinewhich bones have become displaced from their optimal positions, and/or(4) a three-dimensional representation of joint position and congruencyof the foot. A computer software program in the system analyzes thedigital anatomy and, based on the analysis, directs the system or askilled clinician or physician to reposition one or more foot bones,with optional input from the clinician or physician. The digital anatomyof the repositioned foot, with one or more bones in a restored bonestate, is obtained, and the digital data file of both the initial andthe restored bone states are stored, for use in manufacture of orthosesand/or for subsequent evaluation.

FIGS. 3A-3B illustrate components of such a system 10. System 10comprises a surface 12 for receiving a plantar surface of a foot.Surface 12 is of sufficient size to accommodate measurement of any sizefoot. In a preferred embodiment, the system additionally comprises acomputer (FIG. 3B) with software for analysis and diagnosis, as will bedescribed below. The system optionally includes an imaging system (notshown), also discussed below, for complimentary and enhanced analysis ofa foot. The system also comprises a pin matrix, also referred to hereinas a pin bed or array of pins, comprised of a plurality of pins that arecollectively or, preferably, individually and independently moveable.FIG. 3A includes an exploded view of several pins, pins 14, 16 beingrepresentative, in the array of moveable pins. Pin beds are described,for example, in U.S. Pat. Nos. 5,640,779; 4,876,758; 5,941,835;5,689,446; 4,449,264, incorporated by reference herein. In someembodiments, each pin in the plurality is independently moveable and isunder control of a driver, such as drivers 24, 26, coupled to theindividual pins to raise each individual pin at a known or controlledpressure. The drivers in the system can be, for example, a piston drivenby a pressure source, a servo-controlled motor adapted to raise anassociated pin by a preselected distance, a constant force spring, ahydraulic device, a pneumatic device, or the like. A heel rest 18 can beoptionally included at one end of the surface on which the footcontacts. Additionally, surface 12, also referred to as a foot platform,can include stabilizing arms 20, 22 mounted on opposing longitudinalsides of the platform on sliding rails, for application topoint-specific areas of a foot at rest on the surface to stabilize thefoot and permits its adaptation to feet of varying sizes.

FIG. 3C illustrates an embodiment of a pin matrix. In this embodiment,the pin matrix 15 is comprised of two lateral rows of pins, identifiedas rows 17, 19. It will be appreciated that two rows is merelyexemplary, and that the pin matrix can comprise a single row of pins ormore than two rows of pins, such as three lateral rows, four lateralrows, and so on. In one embodiment, the pin matrix comprises frombetween about one to about four rows of pins. The system includes aplurality of drivers, such as driver 21, coupled to the individual pins.The drivers serve to raise, or lower, each individual pin at a known orcontrolled pressure. In some embodiments, a common pressure source (notshown in FIG. 3C) is connected to each driver, and in other embodiments,a plurality of pressure sources are provided with at least one pressuresource connected to each driver.

The rows of pins, in one embodiment, are held on a carriage 23 that ismounted, for example in system 10 of FIG. 3A, for movement across thesurface that receives a patient's foot, such that the pins sequentiallyengage the foot plantar surface, further described below. The systemadditionally comprises one or more sensors for determining positionalinformation about the pins in the pin matrix, and in particular fordetermining a penetration depth of each pin as the pin is raised upwardfrom the surface of the system to enage the foot plantar surface andcompress tissue against bones of the foot. In one embodiment, sensorsfor determining a penetration pressure of each pin as the pin is raisedupward from the surface are provided. A controller is preferablyconnected to the drivers, carriage and sensors, the controllerprogrammed or programmable to sequentially position the carriageincrementally across the foot in an axial direction to scan the entireplantar surface, to raise the pins against the foot tissue at one ormore pressures at each sequential carriage position, to collectpositional information, such as the depth of pin penetration into thetissue, at each pressure and each incremental position, and/or tocontrol pressure applied to each pin.

In use, the pin matrix in conjunction with the other system components,such as a controller and software, can obtain a digital anatomy of apatient's foot. A patient places his/her foot on the surface of thesystem. Pressure is applied sequentially to a series of localizedregions on the plantar surface of the foot, for example by raising thepins in the pin matrix for contact with the foot and compression oftissue against the foot bones. In the embodiment where the pin matrix iscomprised of between about 1-4 rows of pins, such as the embodimentdepicted in FIG. 3C, the pin matrix in a first position is used to applypressure in a first localized region of the plantar surface of the foot,the pin matrix in contact with the plantar foot surface defining a firstlateral band of the foot surface. A first set of positional informationabout the pins in the localized region is obtained. The pressure appliedto each pin can be adjusted one or more times to obtain additionalpositional information of the pins at that localized region. In apreferred embodiment, at least one pressure applied is sufficient todisplace one or more bones of the foot to a restored bone state, andpositional information when the bones are in the restored bone state.The carriage on which the pin matrix is mounted is then movedsequentially, axially across the plantar foot surface to a secondlocalized region on the plantar surface of the foot, where pressure isagain applied to the pins. At each sequential region, or successivelateral band of the plantar surface, in which pressure is applied,positional information of the pins is obtained, from which a digitalanatomy, or an orthotic profile, of the foot can be determined.

It will be appreciated that the number of lateral bands of the footplantar surface depends on the number of rows of pins, the spacingbetween rows of pins, the size of the patient's foot, and other factors.In one embodiment, pressure is sequentially applied to between about10-40 successive lateral bands of the plantar foot surface, morepreferably 15-35, still more preferably 20-30. Each lateral band, in oneembodiment, has a width in the range of about 0.5-4 cm, more preferably0.5-2 cm. The pressure applied to the individual pins in the matrix canbe a common, predetermine pressure or a series of differing commonpredetermined pressures.

The positional information that is determined allows determination of anorthotic profile. Positional information can comprise, for example,positions of the individual pins at one or more pressures. Based on thepositional information of the pins at one or more pressures, an orthoticprofile is determined. The profile is used, as described below, to forman orthotic device that achieves a restored bone state. The positionalinformation obtained can also comprise imaging the plantar surface orrelationship of one or more foot bones, to construct a digital image ofthe foot bones. In a preferred embodiment, the positional information isused to determine a therapeutic orthotic profile that compresses tissuessufficiently to reposition bones to a restored bone state.

In one embodiment, consideration of pin density, height, diameter, headshape, operating modes, pin elevation measurement, pin pressuremeasurement is given, Additionally, software establishing the digitalanatomy, heel rest, foot stabilizing assembly, attachment to a computer,and attachment to an imaging system are considered based on thefollowing features.

With respect to density of the pins in the pin bed, the number of pinsper square centimeter can be varied to optimize for increased resolutionof two- and three-dimensional images. By way of example, pin density canrange from about 0.5 pin measurements per cm² to about 4 pinmeasurements per cm², in one embodiment, for scanning of the foot andbone repositioning. The pin density, in one embodiment, is selected toallow the imaging process to gather a sufficient number of data pointswithout the data collection interfering or adversely affecting the datacollection/measurement itself. In one embodiment, the pins are spacedapart by a distance in the range of about 6 mm to about 13 mm, measuredfrom the longitudinal center line of one pin to the longitudinal centerline of an adjacent pin. More preferably, the pins are spaced apart by adistance in the range of about 7 mm to about 10 mm, and in a preferredembodiment, the distance between center lines of adjacent pins is about8.3 mm (0.325 inch). In a preferred embodiment, the pins are aligned inoffsetting rows to accommodate a high density of pins while avoiding theproblem of “tenting” in which a pin rises into the pressure well createdby an adjacent pin. The diameter of the pressure well is a function ofthe pin's diameter, the depth of penetration, and the physicalproperties of the compressed media, such as the skin or soft tissue. Ina preferred embodiment, the rows of pins in the matrix are configured ina saw-tooth pattern of between, for example, 1-4 rows, preferably ofbetween about 2-3 rows. The saw-tooth pattern or offset position of thepins is seen in the pin matrix of FIG. 3A and FIG. 3C, where the pins inrow 17 (FIG. 3C) are offset from the pins in row 19 (FIG. 3C). Theseoffsetting pin locations are such that as the matrix of pins is movedsequentially to localized regions on the foot surface, the pins in onerow when the matrix is in a first position interlace with the pins inanother row when the matrix of pins is moved to a second position. Thepins are preferably raised simultaneously, but discretely, in eachposition and information on pressure and pin height is collected inorder to determine an orthotic profile or digital anatomy of the foot.The pin matrix when in position at each localized region of the foot maybe subjected to more than one pressure, for example, two or threepressures, wherein at least one pressure is sufficient to displace bonesof the foot to a restored state. A single row of complete data acrossthe foot is thus collected with 2 or 3 measurements. Effectively, thistechnique gathers high density pin data across the foot without havingany sets of pins too close to one another during any given measurementassuring that the measurement is valid without detrimental effects of“tenting”. As noted above, pins are raised into the foot using a driver,such as the drivers identified as 24, 26 in FIG. 3A. It will beappreciated that the drivers can be placed in an alternating patternand/or on two levels, as shown in the exploded view of FIG. 3A.

With respect to pin height, in one embodiment, the pins have a height,denoted by the distance x in the exploded view of FIG. 3A, of at leastabout 7.5 cm above a plate 28 on surface 12. This pin heightaccommodates individuals with a high arch in one or both feet, andpermits accurate height readings of each pin. The maximum height of eachpin in the array forming the pin bed, in one embodiment, is about 10 cm;and in another embodiment is about 11 cm, 12 cm, 13 cm, or 14 cm.

Diameter of the pins is ascertained upon consideration of a balance ofat least two parameters: the pins should be of sufficient diameter tocompress tissue effectively without causing pain, yet small enough toprevent pressure well overlap of adjacent pins. In some embodiments, pindiameter is small enough to provide as many points of reference aspossible and yet thick enough to bear the weight of a heavy human (up to400 lbs.) standing on the machine. In some embodiments, the plurality ofpins can be arranged in a repeating hexagonal pattern to minimizespacing between the pins. In some embodiments, a 50% offset between rowsof pins is envisaged. In some embodiments, an offset triangular grid mayallow greater density of pin placement, as well as increased accuracy ina high-contour plot.

In some embodiments, the pins may have a circular cross section. The pinhead surfaces can be smooth and slightly convex in shape to evenlydistribute forces over the entire pin head surface.

In use, a patient places his/her foot upon the pin bed. The systemapplies a selected pressure to the pins, the pressure applied beingsufficient to compress the soft tissue on the plantar surface of thefoot to create a uniform density of tissue per cubic centimeter at eachpin head surface. Thus, rather than passively receiving pressure fromthe foot and settling into a position based on the topography of apatient's foot, the presently disclosed pin bed or band of pins canactively control the pressure of individual pins. In one embodiment,several phases of pressure can be applied until a desired pressure isreached. Pin pressures can be monitored to assure that the same pressureis delivered to each pin. As can be appreciated, pin heights increaseuntil the pressure against each pin by the foot equals the pressureexerted by each elevated pin. When the two pressures are equal, pinelevation stops and the pins can be measured for pin height andpressure. A digital anatomy of the foot is created based on the positionof each of one or more pins and the applied pressure, and the image ofthe anatomy is digitally stored. Creation and analysis of the digitalanatomy is described below. In one embodiment, after analysis of thedigital anatomy, and with the patient's foot in place on the pin bed,selected pins in the array of pins in the bed are adjusted in an upwardor downward position to adjust and/or reposition selected bones in thefoot, to restore a desired or proper bone position, and tensegritystructure of the body in one embodiment, as determined by the computersoftware. In this adjusted position, the pins are now aligned to mimicthe shape of a custom orthotic and to allow the patient to sample theirorthotic prior to its manufacture. After the bones have beenrepositioned by the pins, another digital anatomy of the restored footmay be created. Though the preferred embodiment does not utilize alocking mechanism or pre-manufacture comfort testing, in one embodimentthe pins can be locked in place using a locking mechanism illustrated inFIG. 3D. In FIG. 3D, a pin 30 extends through a foot plate 32, as seenbest in the lower panel of FIG. 3D. Pin 30 in its unlocked position isshown in the left panel of FIG. 3D, and it is locked position in theright panel of FIG. 3D. In the embodiment utilizing a pin lockingmechanism, the patient can stand on the instrument whose pins are lockedto test the approximate shape of the final orthotic for comfort prior toits manufacture.

In cases requiring a correction to pin heights that are too large toachieve the desired restored bone state in a single orthotic device, aseries of two or more orthoses are designed where the computer definesthe shape and contour of the orthoses to progressively move the bones tothe restored bone state.

In one embodiment, the pins in the array of pins in the bed are elevatedindividually by applying pressure to each pin simultaneously and withincertain tolerances. The height of each pin can be individually monitoredand controlled by computer. Pressure regulation can be controlled by thesoftware yet will also allow for manual adjustment by the practitioner.In other embodiments, pin elevation is optically monitored for each pinby the computer software, and in some embodiments pin height accuracywill be assured to within 0.05 mm or better. As is evident from thedescription above, pin elevations car be measured several times duringthe analysis and diagnosis of a patients foot. An initial pin elevationmeasurement is taken when the pins are in full contact, low compressionagainst the plantar surface of the foot in order to achieve a baselinestatic structural image. After the pins are in full contact with thepatient's foot at low compression, the pressure is then increased,compressing tissue to a uniform density, and the pin elevationmeasurement is (again) taken. The step of increasing pin pressuremeasuring pin elevation is repeated a number of times, resulting in aseries of digital anatomies of the foot. Additional adjustments to thebones may be made by the computer via pin elevation or manually by thepractitioner in order to achieve an optimal restored state. In this way,baseline and corrected images of the foot are documented.

A range of forces between 0 and 50 Newtons can be applied to the pins,and applications of force can occur iteratively. Pin forces willtypically be in a range from 0 to 5 lbs (0 to 30 N) per pin. A typicalpin diameter is from about 0.10 to 0.25 inch (2.5 mm to 6.4 mm).

A heel rest on the foot platform can be included, as illustrated in FIG.3D, to maintain proper shank position. The heel rest can include aremovable or foldable curved bar 36 that stabilizes the heel and lowerleg and minimizes their movement or slippage, yet allows pins to elevatearound the heel area to capture the natural shape. In addition, a curvedbar 38 continues past the level of the ankle malleoli and has anadjustable strap 40 that is positionable about the ankle for betterstabilization in those instances where hypomobility would normallyrequire two people to position the foot for scanning. This bar, in oneembodiment, would have a variable angle to the foot platform with a“normal” notch set at 110 degrees. For most patients this angle willtake tension off of the calf muscles and prevent activation of thetensile components of the foot including the LCNC complex and theinter-tarsal ligament complex while still maintaining proper contactwith the foot platform.

In addition to the heel rest, the foot platform can additionally includea foot stabilizing assembly 42 to hold steady the first and fifthmetatarsal heads so that the tensile elements are not under tension andtherefore the LCNC complex and internal tarsal ligaments are notactivated. The foot stabilizing assembly includes a strap that can beadjusted and fastened in place, using conventional fasteners such as,but not limited to, buckles, hooks, Velcro, loops, or other types offasteners. The foot stabilizing straps are anchored on movable rails sothat any size foot can be accommodated. Under the strap, two elasticpieces (for example rubber or rubber-like pieces) are placed over thefirst and fifth metatarsophalangeal (M-P) joints so that the pressurecreated by the strap applies pressure only over those two joints. Thetwo rubber pieces are shaped to fit smoothly over the first and fifthM-P joints and are attached to the strap in such a way as to allow themto move along the length of the strap, and are therefore adjustable toany size foot. The foot stabilizing assembly may also incorporate atensioning element (such as a spring) that applies a force towards theheel of the foot so that as the pins raise the bones of the midfoot,increasing the height of the medial and lateral arch and reducing thelength of the foot, the foot stabilizing assembly moves toward the heelto accommodate the foot shortening. The foot stabilizing assembly mayalso incorporate a ratchet mechanism that prevents the foot fromlengthening after the pin pressure under the midfoot is released.

With reference again to FIG. 3A. the foot platform is in communicationwith a computer and its software, the communication via, for example,ports and cables or a wireless arrangement. The computer may also belinked to an optional imaging system, described below, also by ports andcables or wirelessly, unless the particular imaging system requires aspecial connection.

Turning now to the software that accompanies the system, the softwareacquires pin height data along with stored information of a generalizedskeleton of the foot to form a three-dimensional representation of theparticular skeletal and soft tissue anatomy of the patient's foot. Pinheight varies depending upon the thickness and density of soft tissuebetween the plantar surface of the foot and the underlying bone. Thesoft tissue beneath weight-bearing bone, such as at the tubercle of thecalcaneus and under the first and fifth metatarsal heads, will be higherin density and harder to compress, resulting in minimal pin elevation.In areas where bones are deeper to the plantar surface, soft tissue maybe thicker and will have a lower density allowing it to compress moreunder the same pressure. In those areas the pins will elevate more toreach pressure equilibrium. The software captures the elevation of eachpin once a uniform density of the foot structures is achieved.

Characteristics of the presently disclosed software are: (i) it enablesdata gathering from pins' pressures and elevations to display graphicrepresentations of various aspects of the foot; (ii) it provides viewingof certain images from any angle; (iii) it contains rules for displayingthe digital anatomy of the foot in two- and three-dimensionalrepresentations, for example, by showing a congruency map optionallyallowing the visualization of articular surfaces of the bone(s), or byshowing a vector map allowing visualization of the bones to bemanipulated, wherein the congruency or vector map can change upon pinadjustment or human manipulation techniques; (iv) it contains rules fordiagnosing structural abnormalities of the foot, for example bydetecting one or more bone alignments and drawing lines 1-4 (asdescribed in Example 2), assessing misalignment(s), and suggestingmovements of one or more bones to achieve a desired angle and/or toestablish congruency; (v) it contains rules for restoring proper bonealignment without overcorrection and automatically detecting andupdating the alignments and redrawing lines (for example, to superimposelines 1, 2 and 3, optionally based on a minimum movements criterion, andto allow the intersection of lines superimposed lines 1-3 with line 4 atapproximately a 90° (+/−3°) angle, as described in Example 2); (vi) itcontains rules for determining, at the diagnostic phase, when serialorthoses are needed (such as when the elevation of pins for moving boneswithin a patient's foot generates intolerable discomfort for thepatient, and/or such that no ligament is stretched beyond a certainpercentage of its original length, even if the patient feels nodiscomfort), and recording the corresponding distances from initialuntreated bone position to the desired and/or prescribed restored boneposition(s), and computing and/or dividing those distances intointermediate segments/steps for determining a series of intermediatebone repositionings needed and designing a series of more comfortableprogressive orthoses, thereby determining the shape of each orthosis inthe series; (vii) it transfers the data for the restored foot to anorthoses manufacturing instrument; (viii) it will determine how muchcorrection can be performed comfortably for each patient based oninformation gathered from the diagnostic mode; (ix) it is able toquantify the relationship between the bones of the foot and quantifytheir respective movements in order to give practitioners guidance andenhance individual patient treatment; and/or (x) it can provide aquantitative digital display of the bones' positions.

The computer software provides a three-dimensional rendering of thecompressed soft tissue of the plantar aspect of the foot at uniform softtissue density, and an overlay of more than one of suchthree-dimensional displays under different compression pressures. Toprovide this rendering, the computer software can simulate the anatomyof the patient's foot, or of a restored foot, using, for example, acolored representation of the topography of the compressed tissue basedon analysis of pin heights The software can also identify the long axisof any bone, annotate the display, and/or prescribe and/or adjust pinheight needed to move one or more bones of bone movement in six degreesof freedom to a restored position. The software can display theprescribed orthotic designed by the system.

The software provides, in some embodiments, the following types ofgraphic representations of the foot measurements. In one embodiment, athree-dimensional color-coded computer simulation of the patient's footskeleton showing bone alignment and joints based upon calculations madeby the software based upon pin height data is provided. In anotherembodiment, a three-dimensional “wireframe” rendering of the compressedsoft tissue of the plantar aspect of the foot at uniform soft tissuedensity is provided. In another embodiment, a customizedthree-dimensional skeletal representation of the patient's footincorporating all data of the digital anatomy into a computer simulationof the foot skeleton is provided.

The three-dimensional simulation can be rotatable for full 360° viewingin all three planes by using a mouse or roller ball pointing device,allowing the practitioner to view the skeletal representation of thefoot from any angle and vantage point.

The software can move some or all of the virtual bones of the digitalanatomy as would occur in an actual foot whenever the practitioner makesan adjustment by moving a single bone. In other words, when thepractitioner makes a single adjustment on the computer, the rest of thebones of the foot move in response, as they would be predicted to movein nature.

Analysis and Diagnosis

After measurement of a patient's foot by placement on the foot platformand movement of the pins to compress the soft tissue on the plantarsurface of the foot to create a uniform density of tissue per cubiccentimeter at each pin head surface, the computer program analyzes thecollected pin height data to determine bone positions of the foot, firstassessing the shape of the inferior surface of the calcaneus. As shownin FIG. 4A, which represents a contour plot of the compressed softtissue of the plantar surface of a foot, ascertained by the computersoftware based upon pin height, the ideal appearance of the shape of theinferior surface of the calcaneus is circular shape, as indicated at 44.If the calcaneus is not in an ideal position, the shape will appear asan oval indicating that the calcaneus is plantar flexed, as visible inthe contour plot of the foot in FIG. 5A, and identified by element 46.The computer then uses this data to conduct an analysis of the foot,using various techniques, one of which is detailed in Example 2 withreference to FIGS. 6A-6F.

In some embodiments, an additional function of the computer includesmeasurement and analysis of a patients uncorrected, unmanipulated footon the pin bed. At the same time, the first and fifth metatarsal headsare held to the pin bed surface still allowing for movement of the restof the forefoot. The computer then sends a signal(s) to the pins inspecific areas for which a bone adjustment to achieve restoration isdesired, to apply one or more thrusts of fixed or increasing pressurefor active repositioning of bone and restoration of foot physiology. Thethrusts may be repeated several times at the clinician's discretion.Variable amounts of such active repositioning and restoration will beachieved. The clinician stops this process when he or she determinesthat no further restoration or repositioning can be achieved ortolerated. A static digital anatomy is then obtained. Thus, the systemitself can be a device actively involved in a treatment plan tosupplement or in place of manual manipulation.

As mentioned above, the system can optionally include an imaging system.An imaging system allows the visualization and display of a virtualrepresentation of the positions of the bones and joint spaces in thefoot. The imaging data that is gathered can be digitized, stored andadded to the data captured from the pin bed to further refine thethree-dimensional computer graphic simulation of the foot skeleton. Thisenables the examining clinician to visualize abnormal bone position in amore detailed manner and to use the system to make the desiredadjustments to the bones of the foot that will restore it to a moreideal or normal structure and function. Some examples of means ofimaging include, but are not limited to ultrasound; an MRI, such as aportable MRI; x-ray, CT scanning or infrared imaging.

In some embodiments, the system additionally comprises an ultrasoundimaging device. In some embodiments, a four-dimensional ultrasounddevice is included that permits visual representation in real time usinga combination of ultrasound data along with a computer program thatyields a simulation viewable on a color monitor. When combined with thepresent system a four-dimensional ultrasound of the foot in combinationwith pin position data and a computer model of a foot skeleton, avirtual representation of the bones of a patient's foot can be obtained,as illustrated in FIG. 3B. In this system, the practitioner need not betrained to read ultrasounds. Practitioner training can be centered oncomprehension and interpretation of a patient's digital anatomy, therelative bone positions and the appearance of an ideal or restored foot.

FIGS. 4-8 illustrate use of a digital anatomy obtained using the systemfor identification of foot pathologies, and ultimate design of arestorative orthosis. FIG. 4A shows a two-dimensional topographicalimage and FIG. 4B shows a three-dimensional wireframe image of the foot.The topographical map is delineated in millimeter increments, with thecrosshatched area demonstrating no elevation of the pins, the shadedarea approximately 1 mm, the stippled area another millimeter, andsubsequent lines denoting further or different pin elevations. A footthat is distributing weight properly will carry approximately 50% of theweight on the calcaneus, about 25% the weight will be carried on thefirst ray, and the rest will be evenly distributed over toes 2 through5. The two-dimensional scan shows that pressure can be related totopography in that the area of the greatest pressure will be less likelyto deform under the pin pressure. Therefore, in FIGS. 4A and 4B, thearea with the least pin elevation (the area bearing the most weight) isover the first, fourth, and fifth metatarsal heads.

In FIG. 5A, an image of an abnormal foot bone structure, the area ofleast pin elevation (the area bearing the most weight) is in the middleof the forefoot, right over the third metatarsal head. In this case, thethird metatarsal head has dropped the medial and lateral metatarsalshave elevated, or there is a combination of both. Looking at thethree-dimensional wireframe image, it can be seen that the medial archis very high (solid arrow), while the lateral arch is very low (dashedarrow). Since there is a small lateral arch, the cuboid has notcompletely collapsed as it is the apex of the lateral arch triangle(identified by the dashed arrow). Therefore, the Soot in FIGS. 5A-5Brepresents a combination of collapse of the mid-foot, dropping the thirdmetatarsal down, along with elevation of the medial and lateralelements. Both the tarsal and metatarsal transverse arches areessentially inverting and becoming “V” shaped because the lateralcuneiform, navicular, cuboid (LCNC) complex has failed, preventing themedial and lateral columns to join together as a single, functional unitduring specific phases of gait. The LCNC complex is shown in the X-rayof FIG. 7. The cuboid is marked with a “C,” the navicular marked with an“N,” and the lateral cuneiform is marked “LC.” In the foot shown inFIGS. 5A-5B, the LCNC ligamentous complex has failed, and the twoideally weight-bearing portions of the forefoot (the first metatarsaland fifth metatarsal) have given way, resulting in the transversemetatarsal arch becoming convex in shape rather than concave with thethird metatarsal head now against the ground and bearing weight.

FIGS. 7-8 are examples of digital images of exemplary feet having amalposition of the calcaneus. FIG. 8A shows a digital image of a foot,where a series of reduction lines are drawn for analysis of the footstructures. A reduction line is drawn through the transverse metatarsal(dotted line), and reduction lines drawn through the long axis of thecalcaneus, the bisection line of the cuboid and the line between thefourth and fifth rays are all overlapping (solid line), indicating thatthe calcaneocuboid joint is congruent in the frontal plane. The angle“theta” between the dotted line and the overlapping solid lines is closeto the ideal of 90 degrees indicating that the transverse metatarsalarch is approximately normal. Though it is congruent in the frontalplane, the calcaneocuboid joint is not congruent in the sagittal planebecause instead of having a circular shape as expected from the circulartubercle of the calcaneus, the digital image of this foot has a longovoid shape. FIG. 8B shows that the lateral column in this foot is flat.It also shows a depression beneath the dashed arrow where the cuboid hasbeen forced downward by the plantar flexed calcaneus. The flat lateralcolumn such as in FIG. 8B is observed in patients who have congenitalpes planus. However, the foot in this figure also shows an ovoid shapeto the calcaneus indicating that it is abnormally plantar flexed andthat the flat lateral column is both abnormal and not congenital. Thisfigure illustrates a classic presentation for a functional short leg.

FIGS. 9A-9B also illustrate a foot having an ovoid shape of a plantarflexed calcaneus, but in this case it is indicative of a functional longleg. The area delineated by the rectangle shows the subtle shift in thedirection of the calcaneus versus the direction of the fourth and fifthray. The dotted lines show the lateral column and calcaneus reductionlines. In an ideal foot, these would overlap, but in this case they donot and their offset angle meets at the cuboid indicating that thecalcaneocuboid joint is no longer congruent. Also, the transversemetatarsal line (solid line in FIG. 9A) makes a theta angle much greaterthan 90 degrees, indicating that this foot has broken down in severalareas. The 3-dimensional image (FIG. 9B) shows that all three arches aredecreased and that the lateral column is very flat.

The computer program of the presently described system performs theabove analysis and suggests a diagnosis or a differential diagnosis foreach patient. The program then prescribes treatment options forpractitioners who wish to manipulate the bones of the foot prior toapplication of an orthosis for restoration of structure and function tothe foot and fabricate the orthosis in-office, as well as for those whowish to have the orthosis or series of orthoses in a treatment planfabricated at another location using this system.

Restoration Based on the Analysis and Diagnosis

To restore the foot to an optimal bone state, the system described aboveidentifies the joints in the foot whose tensile structures haveundergone plastic deformation and then manipulates the foot in silico,or manually, to bring them into congruency.

To achieve this, the patient's foot is placed on the foot platform ofthe system, a digital anatomy is obtained, in one embodiment with thepins of the pin bed adjusted to manipulate the foot into its restoredbone state. This digital anatomy is referred to herein as the“restorative digital anatomy.” In some embodiments, the patient's foothas been manually restored prior to obtaining the restorative digitalanatomy. From the restorative digital anatomy, the system performs anadditional set of calculations, similar to that described above, andmoves the pins into a position to achieve a restored bone state. In oneembodiment the pins can be locked in place, and the pin positionsrepresent the shape/contour of the orthotic to be fabricated. Thepatient can stand on the pin bed to assess comfort, and minoradjustments may be made by the practitioner as needed for comfort or toimprove congruency between one or more foot structures. After anyadjustments to the pins, they are once again locked, the position of thepins evaluated by the software, and the data stored for subsequentanalysis or fabrication of an orthotic device.

It will be appreciated that while the description of the method andsystem set forth above is illustrated using a pin bed for obtaining afoot digital anatomy, the method and system are not limited to a pin bedalone to obtain a digital anatomy. Imaging techniques are alsocontemplated and would be suitable in supplementing the data from thepin bed in constructing the digital anatomy.

The method described herein contemplates serial orthoses in a treatmentplan, in which one or more intermediate orthoses are designed to movethe bones from an initial bone state to a restored bone state. Such aseries of gradually more corrective orthoses moves and stretches softtissues, to move the pathologically positioned bones of the foot intorestored positions. A patient will wear the first orthotic device in theseries for a first period of time selected by the clinician, typicallyon the order of several weeks or months. Then, the patient wears thesecond and any subsequent orthotic devices in the series for a selectedperiod of time, which can be the same or different than the period oftime for the first orthotic device. The sequence continues until thepatient is wearing the final orthotic device that accomplishes arestored bone state.

Another means of effecting restoration is for the system to be modifiedto automatically manipulate the foot in place of the practitioner. Thiscan be accomplished using one or both of the following methods. First,with the foot secured to the pin bed and under minimal weight bearingwith the patient seated, high velocity, low amplitude thrusts in anupward direction are made by pins or groups of pins as determined by theaccompanying software. Second, as the pins are advanced slowly towardthe accompanying software determined restoration position, they areoscillated (or vibrated) rapidly in an up and down direction while thefoot is secured by the retaining device and under minimal seated weightbearing. Both of these methods can be combined where the pins oscillaterapidly up and down and selected pins or groups of pins make periodichigh velocity, low amplitude thrusts in an upward direction untilrestoration is acquired. As a safety measure, the system can optionallycontinue to monitor pin pressure and can stop pin advancement should apredetermined pressure be exceeded.

C. Manufacture of an Orthotic Device

In another aspect, the system further comprises an instrument for themanufacture of one or more restorative foot orthoses. FIG. 11illustrates an embodiment of a manufacturing instrument for use with thesystem. In the example, the manufacturing instrument 60 includes a pinbed 62. The pin bed sits within a vacuum chamber box 64, and extendsapproximately two inches above the rim of the vacuum chamber box. Thevacuum chamber box is attached, via a hose 66, to an evacuation chamber68 that has double the volume of the vacuum box chamber. The evacuationchamber is connected to a vacuum pump 70. In some embodiments, the hoseand opening in the chamber will be sufficiently large enough to evacuatethe entire chamber in less than three seconds. The vacuum chamber boxcan have a hinged cover with an aluminum frame with heavy heat resistantrubber screwed to it for easy replacement, to provide an airtight sealwhen closed.

The pins of the pin bed are covered by a material 72 that serves toprevent the pin heads from pitting the finished product. The pins aremoved into the desired position, determined from the measuring andanalysis described above to move a patient's foot into a restored bonestate. A blank insert, i.e., a flat sheet of a selected material(s) tomake the orthotic, is heated to a temperature sufficient to render itpliable for forming into the shape of the custom orthotic. The blankinsert is positioned over material 72, and the vacuum box chamber inwhich the pin bed is position is closed. A rapidly produced vacuum, viapump 70 in communication with vacuum chamber 68, is applied to shape theorthotic device. After cooling, the orthotic is removed from the pin bedand the edges are smoothed, for example, using a carbide wheel.

The orthotic device is manufactured, in another embodiment usingpressure forming. A pressure former is comprised of two clam shelf boxesarranged such that the top half pressure box is comprised of afive-sided box with an opening on the sixth side. This sixth side iscovered with a rubber-like or elastic membrane and sealed to the rim ofthe box. This box is brought down onto another box frame of the sameperimeter which has its sixth side open and facing up to meet therubber-like membrane. Inside the second box, the mold shape ispositioned in its cavity. A heated and pliable orthotic material isplaced over the mold. The two box halves are then brought together andheld tight with clamps. High pressure air is released into the top boxhalf into the cavity volume that is sealed with the rubber membrane. Asthe pressure builds in this cavity, the rubber-like member stretchesdown onto the waiting orthotic material and forms it to the mold shapewhich it is resting on. The rubber-like member stretches sufficiently toforce the orthotic material to take the identical shape of the mold. Thepressure is held for a few minutes until the orthotic material'stemperature drops below its glass transition temperature. At this time,the pressure in the upper cavity is released, the two halves of thefixture are separated and the molded orthotic shape is removed from themold. Pressures in the forming cavity used typically range from 0 to 6bar (0 to 90 psi).

In another embodiment, the orthotic device is manufactured by millingfrom a positive foam mold. The process of producing the foam mold isdone by milling it using a milling machine. The data set is derived fromthe measured data, discussed above, and manipulated appropriately. Thisfile is then converted into tooling paths which in turn drives the mill.The final foam shape is the shape either the inside or the outside ofthe desired orthotic shape. Tapers, bevels and other features areinserted outside of the data that represents the final shape of theorthotic that bridge the mold to a base so that the mold can bepositioned and held appropriately in the pressure or vacuum formingtools.

In another embodiment, the orthotic is manufactured using the pin bed ofthe device. In this embodiment, the computer software of the systemretrieves the data used in the measuring and analysis of the digitalanatomy to reproduce the identical pin configuration for manufacture ofthe orthosis, except that it is converted to a positive image. Forexample, the locked gauging elements of a pin bed can provide a form toserve as a positive mold for fabricating an orthotic. In other words, itwill assume the shape of the bottom of the foot with the restoration.Data for a particular patient is sent from the computer in the systemdescribed above to the pin box in the manufacturing unit, and the pinsrise to the patient specific, restored shape. The already heatedorthotic blank is then seated on the pin bed.

Once the presently disclosed orthotic has been constructed, it can thenbe sandwiched between two covering materials, in one embodiment, beforeproceeding to packaging and shipping. These coverings can beindividualized to the patient's tastes and needs. For example. a topcovering of the neoprene product identified by the tradename Neolon®(Medline Industries, Inc.) enhances patient comfort and helps keep thefoot well seated. Furthermore, a leather bottom enhances the fit of theorthotic in the shoe and minimizes movement of the orthotic within theshoe. Finally, both layers uniformly increase the post of the orthosiswithin the shoe. It should be noted that alternative top layers may beused in special situations. A top covering of, for example a closed foampolyethylene, such as Plastizote® (Zotefoams, Inc), provides cushioningand is bacteriostatic, which may be suited for particular patients orconditions. In another example, women using the orthotic primarily indress shoes may prefer a top layer that is also made of leather that isthin and also helps keep the foot in place within the shoe. Otherorthotic top and bottom coverings may be used as they do not affect thestructure and function of the device itself.

Materials suitable for forming an orthotic device are known in the art.In general, materials that form orthotic devices with one or more of thefollowing properties are suitable: (i) energy storage and return, (ii)thermoplastic that is easily molded under heat and vacuum, (iii) atensegrity weave and aramid to prevent fracture, (iv) small load range(movement from zero to full capacity), and (v) skid resistantundersurface to minimize insert movement within the shoe. Commonmaterials include ethyl vinyl acetate (EVA), which comes in variousdurometers, and polymer plastics such as polyethylene, polypropylene, orco-polymer plastics.

In some embodiments, an orthotic is made of a carbon and aramidtensegrity weave, optionally impregnated with acrylic and a plasticizer.Because aramid fibers have a short “toe region” like collagen (as seenin FIG. 1), appliances manufactured from an aramid fiber, such as abullet-proof vest, effectively and rapidly absorb and dissipate force,such as force of a bullet. Graphite, which is more commonly used alonein rigid orthoses, dissipates energy to a significantly lesser degree.In another embodiment, a combination of two materials is used, providingan orthotic material which stores and returns energy (like graphite) andalso prevents fracture (like aramid) when greatly stressed. Acarbon-aramid weave can be impregnated with a thermoplastic, conveyingthe ability to create blanks and heat-vacuum mold them into customizedorthotics. One suitable thermoplastic is a semi-crystallinethermoplastic, conveying the ability to flex and return to its formedshape many times before cracking.

The weave of the carbon and aramid is preferably loose enough to changeits conformation within the thermoplastic so that it can form the radiithat control osseous position, yet it maintains a tensegrityconformation, as illustrated in FIG. 10, to withstand the stresses ofgait, especially running. A tensegrity weave impregnated with athermoplastic of an appropriate ratio of acrylic to plasticizer givesboth the required energy storage and energy returns within prescribedtemporal limits. The presently disclosed orthotic materials provideenergy storage and return within a narrow range of time such that thearches of the foot and the intercuneiform linkage can function yet notcollapse as did its previously supportive tensile structures ofligaments, tendons and fascia.

In another aspect, an orthotic device is provided. The device ispreferably designed according to the methods described herein, and/orthe system described herein. The orthotic device preferably has aminimum of three layers: a top and bottom cover and a custom moldedcenter. An exemplary orthosis 130 is illustrated in FIGS. 13A-13C. Withinitial reference to FIG. 13A, the medial and lateral sides of thedevice are indicated at 132, 134, respectively. The proximal end. wherethe calcaneus bone, or heel, of the foot sits, is indicated at 136, andthe distal end is indicated at 138. As best seen in FIG. 13B, where askeleton of a foot is shown placed on the exemplary orthotic device, theorthotic device is sized such that the distal end terminatesapproximately at the metatarsophalangeal joints of the foot, indicatedat 144. That is, the custom molded center layer is sized to extend fromthe proximal end of the foot (e.g., the proximal surface of the heel) toa terminus defined by a line running approximately ⅓ of the metatarsal'slength proximal to the first metatarsal head, just proximal to thesecond, third and fourth metatarsal heads tapering back so it isapproximately ⅓ of the metatarsal's length proximal to the fifthmetatarsal head producing a support for the transverse metatarsal arch.It will be appreciated that in other embodiments, the device can besized to extend from the proximal end of the foot to contact all or aportion of the phalanges.

With reference again to FIG. 13A, arrow 140 designates a line drawn onthe orthotic device that denotes the region and contour of the orthoticdevice that is referred herein as the “saddle” of the orthotic andidentified by arrow 146. This area is custom molded to reduce oreliminate any abnormal plantar tilt of the calcaneus, i.e. control thecalcaneus in the sagittal plane. This is needed because the calcaneusplantar flexes as plastic deformation occurs in the long and shortplantar ligaments causing incongruency of the calcaneocuboid joint withthat joint space widening along its plantar surface. When the calcaneusis lifted back to its correct position, the calcaneocuboid joint'scongruency is restored. Also seen in FIG. 13A is a marked region 142that is referred to herein as the “LCNC Dynamic Post” . The LCNC DynamicPost region of the device is a convex area, with the base of it definedby four points, designated as 1, 2, 3, 4, in FIG. 13A: 1) the mostinferior part of the head of the first metatarsal, 2) a calculated pointbetween the most inferior parts of the fourth and fifth metatarsalheads, 3) the most inferior point of the lateral side of thecalcaneocuboid joint, and 4) the most inferior point of the medial sideof the calcaneocuboid joint. The apex of the LCNC Dynamic Post isdefined by the highest point on the undersurface of the secondmetatarsal, which lies about one third of the way proximal to the secondmetatarsal head. It will be appreciated that the LCNC Dynamic Postvaries in size depending on the patient. In FIG. 13B it is seen that thesaddle 146 is under the transverse tarsal arch and the LCNC Dynamic Postis under the metatarsals (arrow 148).

Based on the foregoing, and in particular with respect to FIG. 12 andFIGS. 13A-13B, it can be appreciated that the orthotic devicecontemplated herein is, in one embodiment, shaped and/or contoured tocomprise a convexity herein referred to as the LCNC Dynamic Post (seeregion denoted by the dashed line indicated by arrow 120 in FIG. 12),such that the convexity supports at least the Lateral Cuneiform,Navicular and Cuboid bones, i.e. the LCNC complex, but does not lock itinto one position, thus allowing the LCNC complex to function normallyduring gait. The orthotic device, in another embodiment, is designed andshaped to achieve a restored bone state by supporting the LCNC complex.In yet another embodiment, the orthotic device is designed and shapedfor an individual subject to achieve a restored bone state by supportingthe LCNC complex and/or one or more bones in the midfoot region, by aconvex region on the device situated for such support.

In another embodiment, the orthotic device is contoured with a sagittalplane convexity in what is herein referred to as the “saddle”, toprovide a supportive area in front of (distal to) the heel cup. Theconvex support structure of the Saddle functions to support thecalcaneus in the sagittal plane and the cuboid bone which helps torestore congruency of the calcaneocuboid joint, and helps to support theLCNC complex along with the LCNC Dynamic Post.

Another feature of the orthotic device is the radii or radius ofcurvature, i.e, the amount of curvature, imposed on the orthoticmaterial, particularly in the convex and concave regions of the device.The radius of curvature of the convex regions, and in some cases anyconcave regions, is selected to lend strength and support yet preventcracking and failure of the orthotic material. The radius of curvatureof the convex and concave regions of the device are specifically placedand shaped to provide dynamic support to selected foot structures,mimicking the viscoelastic properties similar to human ligaments, whichrestores joint congruency and allows restored foot motion to occur.

The device, in another embodiment includes one or more concave regions,for example, a heel cup in which the calcaneus rests. In a preferredembodiment, the heel cup is unique in that it is used to hold the heel(calcaneus) in the correct position in the sagittal plane so that thecalcaneocuboid joint and the LCNC complex will be congruent. In contrastto prior art orthotics that have heel cups, the concave heel cup regionof the present device is contoured such that movement in the frontalplane is not prevented. This heel cup is not designed to lock thesubtalar joint (STJ) into a neutral position as is often done in priorart rigid or semi-rigid orthotics. Instead, the heel cup and Saddlesupport the restored position of the calcaneus in the sagittal planerestoring congruency to the subtalar joint and allowing it to movephysiologically in the frontal plane.

From the foregoing, it is appreciated that the functional uniqueness ofthe orthotic device described herein provides a process of restoringbone positioning and restoring joint congruency, and to allow normalfoot motion and function during gait. Orthotics known in the art priorto the device described herein were typically rigid and acted like asplint to hold the foot in a position that maintains subtalar neutral.Such orthotics do not allow normal foot motion or function to takeplace. Any initial pain relief is generally due to the splinting effectof painful joints by the rigid orthotic. The other broad category oforthotics, accommodative orthotics, is soft and does not support jointcongruency and does not restore normal foot function. Lastly, prior artsemi-rigid orthotics are no more than a compromise between a rigidorthotic that is painful during gait and a soft, accommodative orthoticthat provides cushioning but lacks support. None of these prior artorthotics restore joint congruency or physiologic foot function

With reference to FIG. 13C, the orthotic device is shown in side view.As seen, the trim line of the orthotic may be turned upward as indicatedby the region encompassed by arrows 150 a, 150 b, 150 c, 150 d. Whilemany orthoses can and do have this type of trim line, the orthotic ofthe present application differs in that the high lateral trim line andthe imposed radii, in conjunction with the device fabricated from atensegrity-weave material acts to give the orthotic added rigidity andstrength. Preferred exemplary weave material are described in U.S. Pat.Nos. 4,774,954 and 4,778,717, which are incorporated by referenceherein. The composite materials are prepared from two layers of fabricmaterial comprised of fibers of carbon, glass or aramid, where thelayers can be woven threads, unidirectional fibers or random strandmats. The resulting materials are rigid, thin, and lightweight. A coreof a thermoplastic material, such as an acrylic material, is included inthe composite material to render the material thermoplastic. Anothercomposite material is made of layers of woven fabric and biaxiallyreinforced fibers, the layers being bonded together with a thermosettingadhesive (see, U.S. Pat. No. 4,774,954). Materials for the fibersinclude, but are not limited to, the synthetic aramid fiber identifiedby the trademark Kevlar®, graphite, and e-glass.

Another exemplary foot orthotic device is illustrated in FIGS. 14A-14F.Orthotic device 170 is formed of a substrate 171 that has a proximalheel region 172, with a concave contour to accept the heel of apatient's foot. The shape and extent of the concavity in region 172 isdesigned, in some embodiments, to achieve congruency between the LCNCcomplex and the calcaneocuboid joint. A distal region 174 of the deviceis designed and sized for a custom shape with the terminal edge 176 ofthe device terminating at approximately the metatarsophalangeal jointsof the foot, when the device is in contact with a foot. As seen,terminal edge 176 in this exemplary device is not a straight or gentlycurved edge, but undulates, as best seen in FIG. 14A and FIG. 14C, toachieve an individualized point of contact with one or more footstructures for a particular patient requiring a particular repositioningof a midfoot bone. The undulation of edge 176, in this embodiment,provides a projection region 178, best seen in FIG. 14C, that providescontact with, and foot structure adjustment to, one or all of thesecond, third or fourth metatarsals and allows the first and fifthmetatarsal heads to have contact with the ground thus restoring thetransverse metatarsal arch. A convexity 180, best seen in FIG. 14D, ispresent in the projection region 178 to achieve the desired adjustmentto the foot structures.

With continuing reference to FIGS. 14A-14F, device 170 also includes aconvex region 182, seen best in FIG. 14F, that correspondingly engagesthe Saddle region of a foot, to adjust and reposition a particularmidfoot structure, preferably a bone in the midfoot, to restorecongruency to foot bones that are determined by the method describedherein to be out of congruency. Medial side 184 of device 170 iscontoured, as seen in FIGS. 14C and 14F, to engage the arch of the foot.It will be appreciated that the extent of curvature in the region of thedevice that contacts the foot arch can be tailored for individualpatient foot shapes and needs.

It will be appreciated that the foot orthotic devices illustrated inFIGS. 13-14 are exemplary, and that the actual contour of the devicewill vary accordingly for particular patients. The devices as shown arein the form of an insert that can be removably placed in footwear.However, footwear designed with a non-removable or permanent sole thatacts as the custom, individualized foot orthotic is contemplated. In oneembodiment, the orthotic device is a unitary structure, which intendsthat the device is not a laminate device or is footwear having apermanent sole that is the orthotic device. Orthotics designed in accordwith the methods and systems described herein are also contemplated foruse in any orthopedic device, including but not limited to casts of alower extremity. It will also be appreciated that the methods andsystems described herein can be used to design a shoe last, formanufacture of a shoe having a sole customized for a patient and thatpositions one or more bones in the patient's foot into a restored bonestate.

It can be appreciated that the methods and systems for designing a footorthotic, and the foot orthotic device, are not limited to anyparticular disease, condition, or patient complaint. However, in someembodiments, treatment of specific patients and/or conditions iscontemplated. In one embodiment, a person suffering from diabetesmellitus and experiencing a foot ulcer is treated according to themethod and system described herein. A digital anatomy of the foot isobtained, and a restored bone position is determined that will relievepressure during walking and standing in the foot ulcer region. Anorthotic device is manufactured that positions the foot bones in therestored bone position, thus alleviating pain during walking andstanding, and permitting the ulcer to heal.

In another embodiment, a patient presenting with a Morton's neuroma istreated according to the method and system described herein. A digitalanatomy of the foot is obtained, and a bone position is determined thatwill relieve pressure during walking and standing in the foot ulcerregion. An orthotic device is manufactured that positions the foot bonesin a restored bone position, thus alleviating pain during walking andstanding, and permitting the ulcer to heal. In other embodiments, themethods, systems and orthotic device described herein are used to treatfoot disorders in athletes, such as plantar fasciitis or Achillestendonitis, to treat adult acquired flat foot syndrome, to treat gait orfoot disorders associated with neurological disorders such as multiplesclerosis, muscular dystrophy, cystic fibrosis, and to improve gait inamputees.

It will be appreciated that the methods and systems described herein arenot limited to design of orthotic devices. but are additionallycontemplated for use more generally in evaluating bones, joint, andtissues anywhere in the body. For example, the methods and systems canbe applied to the wrist or arm, for example in a patient complaining ofcarpel tunnel syndrome. or to the back in a person with back pain. Useof the methods and systems to obtain a digital image of any body regionis contemplated, and exemplary embodiments include but are not limitedto the knee, the ankle, the hip, the elbow, a finger, the shoulder, theneck, etc.

FIG. 15 is a block diagram showing some of the components typicallyincorporated in at least some of the computer systems and other devicesperforming the described methods. These computer systems and devices1300 may include one or more central processing units (“CPUs”) 1301 forexecuting computer programs; a computer memory 1302 for storing programsand data while they are being used; a persistent storage device 1303,such as a hard drive for persistently storing programs and data; acomputer-readable media drive 1304, such as a CD-ROM drive, for readingprograms and data stored on a computer-readable medium; and a networkconnection 1305 for connecting the computer system to other computersystems, such as via the Internet. While computer systems configured asdescribed above are typically used to support the operation of thefacility, those skilled in the art will appreciate that the facility maybe implemented using devices of various types and configurations, andhaving various components.

III. EXAMPLES

Aspects of the present teachings may be further understood in light ofthe following examples, which should not be construed as limiting thescope of the present teachings in any way.

Example 1 Measurement of a Patient's Foot to Obtain a Digital Anatomy

A patient experiencing pain in the left foot during physical activity isprovided. The patient is seated and her bare foot is placed, underminimal weight-bearing conditions, on a foot platform having a pin bedcomprised of an array of independently moveable pins. The pins withinthe pin bed are moved up toward the plantar surface of the foot by meansof servos under control of a computer. A baseline reading of thepatient's foot is acquired with the pins gently touching the plantarsurface of the foot. The “ball” of the heel and first and fifthmetatarsal heads ideally results in 0.0 mm pin elevation. In someembodiments, the pins are flush with the surface of the bed with thebaseline reading taken when a small amount of pressure (that will notdisplace any soft tissue) is applied to the pins to elevate them justenough to touch the plantar surface of the foot. Pin height is displayedin small increments (0.10 to 0.05 mm) and measurement of pin elevationis used by the computer software to produce graphic representations,such as that shown in FIG. 4A, or a three-dimensional wireframe imagesuch as that shown in FIG. 4B.

Then, a selected pressure is applied individually to each pin or groupsof pins to achieve compression of the soft tissue on the plantar surfaceof the foot to a uniform density per pin head which is dictated by theunderlying osseous structures and the thickness and density of the softtissues. For example, even though all pins are under the same pressure,a pin that pushes into an area of the foot that has a thin covering ofsoft tissue over a bone will elevate a smaller amount than a pin thatpresses into a thick area of soft tissue that does not have underlyingbone. Measurements of pin elevations under the selected pressure areused by the software to produce graphic representations of the foot.Measurements of pin elevation may be taken under multiple pressures tocreate a series of graphic representations.

Example 2 Analysis of a Digital Anatomy

A patient's foot is placed on a foot platform comprising a pin bed. Apressure is applied to the pins in the bed to compress the soft tissueon the plantar surface of the foot to create a uniform density of tissueper cubic centimeter at each pin head surface. The computer programcollects pin height for each pin and analyzes the information todetermine bone positions of the foot, first assessing the shape of theinferior surface of the calcaneus. As seen in FIG. 4A, the inferiorsurface of the calcaneus in a healthy or restored foot is a circularshape. If the calcaneus is not in an ideal position, the shape willappear as an oval indicating that the calcaneus is plantar flexed, asvisible in the contour plot of the foot in FIG. 5A. The computer thenuses this data to conduct an analysis of the foot, using the followingexemplary technique based on the digital image shown FIG. 6A.

The computer constructs four lines starting with an image of scannedfoot, as shown in FIGS. 6B-6F:

Line 1 (identified in FIG. 6C as solid Line 1): The computer softwarewill automatically fit an oval over the part of the calcaneus closest tothe ground and use its long axis to define Line 1.

Line 2 (identified in FIG. 6D as solid Line 2): The computer softwareidentifies the hourglass shape of the cuboid, as indicated in FIGS.6B-6F, by the dashed trapezoidal shaped on the digital imagecorresponding to the position of the cuboid, and draws a reduction linethrough the middle of the proximal end of the cuboid, through the middleof the distal end of the cuboid, bisecting the proximal and distalsurfaces of the cuboid. This line is identified in FIG. 6D) as Line 2.

Line 3 (identified in FIG. 6E as solid Line 3): The computer softwaredraws a line in the space between the fourth and fifth metatarsals ofthe foot (between the fourth and fifth rays). The software willdetermine the locations of the bases and the heads of the fourth andfifth metatarsals, as illustrated by the region denoted by the dottedline in FIG. 6B. The computer software then draws a line between thefourth and fifth metatarsals using the two points that lie between thefourth and fifth bases and heads, respectively. This line is identifiedas Line 3 in FIG. 6E.

Line 4 (identified in FIG. 6F as solid Line 4): The computer draws areduction line calculated by the software from the center points of thefive metatarsal heads. This line is identified in FIG. 6F as Line 4.

The Transverse Metatarsal Angle (TMA) is an angle created by theintersection of Lines 3 and 4, indicated in FIG. 6F as “theta”, andshould be 90° in the ideal physiological setting. The software usesthese four lines along with pin elevation data to determine how to movethe bones of the foot so that lines 1, 2 and 3 will become superimposedand so that line 4 intersects the three superimposed lines atapproximately a 90° (+/−3°) angle, creating a custom simulation of therepositioning of the bones of the foot. If additional imaging is used,this data is supplemented to the pin box data.

The Heel Cup: The computer software then measures the angles formed bythe lateral and medial sides of the calcaneus as they relate to theground. This evaluation is most clearly seen in the graphicalrepresentations shown in FIGS. 4B and 5B. The goal is for the anglescreated by each side of the calcaneus as it relates to the ground to beequivalent, while the lateral side of the calcaneus can only be elevatedto the point where the calcaneocuboid (CC) joint remains/becomescongruent. Moving the lateral side of the calcaneus to be moreperpendicular to the ground will increase the angle of the medial orlateral longitudinal arches. The increase in arch angle is usually muchgreater on the medial side. If this proves to be uncomfortable for thepatient, the computer is programmed to incrementally decrease theelevation of the medial arch.

Example 3 Analysis of a Digital Anatomy

A digital anatomy of a foot is obtained as described in Example 1. Threeseries of calculations are performed by the system software to design arestorative foot orthotic device.

First, the calcaneocuboid (CC) and LCNC congruencies are calculated bydrawing and evaluating several lines which transect 1) the long axis ofthe calcaneus footprint, 2) the axis formed from the bisection of theproximal and distal surfaces of the cuboid, 3) the space between thefourth and fifth rays (which will exhibit a deviation if thecalcaneocuboid joint is dysfunctional). Additionally, a reduction lineis drawn through the curve of the metatarsal heads that should bisect aline going through the lateral column in a nearly perpendicular fashion.Second, the software program defines the angle of the calcaneus anddefines the heel cup. Third, the software program delineates the areaunder the midfoot to be supported by LCNC Dynamic Post, now to bedescribed with reference to FIG. 12. In FIG. 12, the positioning of theLCNC Dynamic Post begins with defining a semi-circle where the calcanealapophysis sits by identifying the upward angle of the calcaneus endingat the transverse tarsal joint where the cuboid and navicular articulatewith the calcaneus. This corresponds to the area of the oval identifiedby arrow 120 in FIG. 12. Oval 120 seen in this figure correspondinglyaligns mostly with the cuboid bone, as the rounded inferior surface ofthe navicular becomes part of the proximal medial longitudinal arch. Thegolf club head-shaped area delineated by the dotted line identified byarrow 122 is the major supportive structure of the LCNC Dynamic Post.Its apex corresponds to the metatarsal apex under the second and thirdmetatarsals. The angles of descent and elevation in the LCNC DynamicPost are unique to each foot, but the golf club head-shaped area mirrorsthe foot in an ideal, stable position. Thus, the post need not hold theweight of the body, but rather it holds the articulations of foot bonesin a congruent position as the foot holds the body weight. The LCNCDynamic Post becomes flat abruptly at the metatarsal heads, shown as thefive oval solid circles in FIG. 12, designated 124 a, 124 b, 124 c, 124d, 124 e. This corresponds to the curved club-shape of the metatarsalheads (in the sagittal plane) and allows free weight distribution fromone metatarsal head to the next during gait. While not wishing to bebound by any particular theory, it is believed that the larger surfacearea present at the first metatarsal head is likely explained by thelarger diameter of the first metatarsal head and, when considered withthe sesamoid bones, this diameter approximates double the diameter ofthe second metatarsal. This information can be displayed to thepractitioner on a computer screen and/or it can be saved on digitalmedia.

For restoration of the calcaneocuboid (CC) joint and LCNC complexcongruencies, the computer calculates the bone movement needed to makeLines 1, 2 and 3 illustrated in FIGS. 6B-6F congruent and to achieve aTMA of 90°. The LCNC Dynamic Post can also be defined by the computerand an orthotic can be custom shaped to ensure the arches supportthemselves rather than requiring the arches to bear weight as incurrently available functional orthoses. The initial base of the LCNCDynamic Post can be determined by four points that are acquired andcalculated by the system: (a) the most inferior part of the head of thefirst metatarsal; (b) a calculated point between the most inferior partsof the fourth and fifth metatarsal heads; and (c) the most inferiorpoint of the lateral side of the calcaneocuboid joint. By restoring thetarsal bones positions, the foot can function in a more physiologicallyoptimal manner, flexing and locking when required.

The apex of the LCNC Dynamic Post can be identified using pin bed data,placing the apex of the ridge at the highest point on the undersurfaceof the second metatarsal. This point lies about one third of the wayproximal to the second metatarsal head.

The first metatarsal head along with its sesamoid bones are weightbearing structures that do not require orthotic support and must be atground level for proper toe-off. The computer software program cansubtract out this area and bring the pins down to zero elevation afterthe initial base of the LCNC Dynamic Post is established.

Thus, the computer can establish an outline of the final base of theLCNC Dynamic Post, wherein the outline curves proximal to the head ofthe first metatarsal. The three-dimensional shape of the LCNC DynamicPost can be created by the computer connecting all the above points onthe final base outline back to the apex (described above) by followingthe curvature of the overlying corrected bones.

For restoration of the heel cup, the computer can measure the lateraland medial calcaneal angles. If they are not roughly equivalent, thecomputer can vary the configuration of the LCNC Dynamic Post.

Using the methods and system described herein, the computer can analyzeand evaluate trade-offs for the recommended design of a custom orthotic.

Example 4 Design of an Orthotic Device

A system can be used for design of an orthotic device, wherein thesystem comprises a foot-measuring and analyzing bed or platform having aplurality of individually moveable gauging elements such as pins.wherein the gauging elements are moveable when in contact with a footplaced on the bed or platform and can be moved to a desired position;and a computer program for analysis of a digital anatomy and evaluationof the relationship between two or more bones in the foot, and fordetermining an adjustment to one or more gauging elements of thefoot-measuring and analyzing bed or platform; and, optionally, a displaycapable of displaying digital anatomy of the foot.

Example 5 Manufacture of an Orthotic Device

The manufacturing instrument can be a pin box, as illustrated in FIG.11, for example. Other features of the manufacturing instrument caninclude: (i) pins covered by a durable, smooth and pliable material(such as a tensegrity-weave material, rubber, etc.) that will conform tothe specific pin configurations from many patients, and thick enough toprevent the pin heads from pitting the finished product. The computerwill compensate for this thickness; (ii) pins which can be moved intoposition by the computer and locked in place; and (iii) a blank insert(such as a flat sheet of the material(s) being used to fabricate theorthotic) which will be heated to a temperature (dependant on thematerial) to confer pliability sufficient to allow the material to bepressed into the shape of the custom orthotic. The blank insert can bepositioned on top of the covered pins, the housing of the manufacturinginstrument closed, and a rapidly produced, strong vacuum applied toshape the orthotic. After cooling, the orthotic is removed from themachine and the edges can be smoothed using a carbide wheel.

Example 6 Treatment Plan

Patient #1: Chief complaint: A 66 year old white male presented withbilateral foot pain for an unknown period of time which had graduallyincreased to a severe burning and aching pain associated with swelling,tingling and some weakness.

History of the chief complaint: Patient denied specific injury andstated the pain gradually and progressively increased over a period ofmonths. The pain was partially relieved with stretching the foot, rest,and exercising the foot. The pain was worsened by prolonged exercise,sitting for a long period of time, prolonged walking (for example afterthe first few holes of a round of golf), and standing upright.

Prior treatment for the chief complaint. Patient used custom functionalorthoses on both feet and arrived for evaluation wearing them in bothshoes. He admitted to continued pain while wearing the orthotics.

Past medical history: High blood pressure, benign prostatic hypertrophy,renal adenoma. Past Surgical History: Bilateral inguinal hernia repairs.

Physical Exam: General appearance: Healthy, well built, and appeared tobe in some discomfort. Feet: There was 1+ (on a 0 to 3+ scale)non-pitting edema to both feet with a few petechiae near the ankles,callous formation at the heel, medial to the first metatarsal head andlateral to the fifth metatarsal head. The feet were hypermobile betweenthe rear foot and mid foot. Because of this hypermobility, his medialand lateral columns were dysfunctional and the foot was pronated. Pulsesand sensation were intact bilaterally. Back: Mild lower lumbartenderness without swelling or decreased range of motion. The remainderof the physical exam was unremarkable.

Diagnosis:

-   -   1. Plantar fasciitis    -   2. Hypermobility of the midfoot    -   3. Functional hallux limitus    -   4. Mild tarsal tunnel syndrome.

Clinical Course:

The patient's feet were manipulated to restore ideal congruency to thejoints of the midfoot and first ray of the foot. This was performed byraising and rotating the cuboid while also elevating the navicular andlateral cuneiform until congruency was established.

The patient was then scanned on a pin bed machine. The left foot scannedas being in ideal congruency but the right foot showed that the lateralcolumn was still depressed. The right foot was re-manipulated using animpulse adjusting instrument. The foot was then re-scanned and showedcongruency within normal limits. Both feet were taped and the patientwas instructed how to do this himself at home until the orthotics couldbe delivered to him.

Orthotics were manufactured according to methods disclosed herein. Untilthe orthotics were delivered, the patient continued to tape his feet andreported excellent results including the ability to walk and play 18holes of golf without foot discomfort for the first time in years.

Upon beginning wearing the orthoses, the patient reported continuedrelief of his symptoms. After three weeks of orthotic use, the patientcontinued to report relief of symptoms and continues to wear theorthotics daily.

Example 7 Treatment Plan

Patient #2: Chief complaint: A 46 year old white female complained ofsevere bilateral, aching pre-tibial area pain and mild aching foot pain.

History of the chief complaint: The patient reported the pain began inJuly 1991 while she was standing and walking for prolonged periods oftime over consecutive days in her position as a medical resident.Secondary symptoms included moderate aching neck and upper back painwhich were present since 1979 but worsened after onset of the footsymptoms. Symptoms were worsened by standing and walking. Symptoms wererelieved by rest and elevation of the feet.

Prior treatment consisted of non-steroidal anti-inflammatory agents. Thepatient had never worn orthotics.

Past medical history and past surgical history were unremarkable.

Medications: Patient used non-steroidal anti-inflammatory agents asneeded for foot or neck pain.

Physical Exam: General appearance: Healthy, well nourished, physicallyfit and in no distress. Legs and feet: Both feet appeared normal withthe exception of a mild callus under the third metatarsal head. Therewas 1+ (on a 0 to 3+ scale) pre-tibial swelling with shiny skin and mildtenderness in that area. The feet were not swollen and had normalsensation. However, pedal pulses were slightly decreased (3+ out of 4)bilaterally. The patient had bilateral medial-posterior tibialtenderness indicative of shin splints. Plantar and dorsiflexion of bothfeet were uncomfortable at the extremes. Both feet showed intact medialand lateral columns but the linkage between them was partially brokendown (the LCNC Complex was dysfunctional). Neck and Back: Increasedlordotic and kyphotic curves to the neck and back. There was mildthoracic back tenderness. The rest of the exam was unremarkable.

Diagnosis:

-   -   1. Plantar fasciitis    -   2. Chronic anterior compartment syndrome    -   3. Pathologic gait    -   4. Cervical and thoracic myofascial pain

Clinical Course:

Effleurage of both legs was performed followed by manipulation of bothfeet with the goal of improving joint mobility. Manual manipulationelevated and rotated the cuboid while also elevating the navicular andlateral cuneiform such that joint congruency was attained in the midfootand lateral column. The feet were scanned on a pin bed machine and werefound to be within normal limits.

The patient's feet were then taped and the patient was instructed how totape them herself at home until the orthotics could be manufactured anddelivered.

Orthotics were manufactured according to methods disclosed herein. Afterdelivery of the orthotics, the patient went on a ski trip but did notuse the orthotics or tape while skiing. She reported severe pain whileskiing. After returning home, the patient inserted the orthotics in NewBalance™ athletic shoes and reported complete relief of all symptomswithin one day. After two weeks of orthotic use the patient reportedcontinued relief.

While various embodiments have been illustrated and described by way ofexample, it is not intended that the present teachings be limited tosuch embodiments. Although specific terms are employed herein, they areused in a generic and descriptive sense only and not for purposes oflimitation. Similarly, various changes can be made to the teachingswithout departing from the spirit and scope of the present teachings.Thus, the present teachings encompass various alternatives,modifications and equivalents, as will be appreciated by those of skillin the art.

All literature and similar materials cited in this application,including, but not limited to, patents, patent applications, articles,books, treatises, internet web pages and other publications cited in thepresent disclosure, regardless of the format of such literature andsimilar materials, are expressly incorporated by reference in theirentirety for any purpose to the same extent as if each were individuallyindicated to be incorporated by reference. In the event that one or moreof the incorporated literature and similar materials differs from orcontradicts the present disclosure, including, but not limited todefined terms, term usage, described techniques, or the like, thepresent disclosure controls.

1. A method for determining an orthotic profile, said method comprising:applying pressure with an array of movable pins applied in a sequentialseries to localized regions on a plantar surface of a patient's foot,the localized regions receiving different pressures in each step of thesequential series, wherein at least one pressure is sufficient todisplace a bone of the foot to a restored bone state; obtainingpositional information from the array of movable pins when the bone isin the restored bone state; and determining the orthotic profile basedon the positional information.
 2. A method as in claim 1, whereinapplying pressure comprises applying pressure across successive lateralbands of the plantar surface.
 3. A method as in claim 1, whereinapplying pressure comprises applying pressure sufficient to displace abone in the mid-foot.
 4. A method as in claim 3, wherein applyingpressure comprises applying pressure sufficient to displace a mid-foottarsal bone.
 5. A method as in claim 1, wherein the pins are spacedapart by a distance in the range from about 6 mm to about 13 mm.
 6. Amethod as in claim 1, wherein at least two lateral rows of pins aresimultaneously engaged against the plantar surface.
 7. A method as inclaim 1, wherein the at least one row of pins is moved incrementallyacross the foot in an axial direction to scan the entire plantarsurface.
 8. A method as in claim 1, wherein obtaining positionalinformation comprises determining the positions of each individual pinin the array.
 9. A method as in claim 1, wherein obtaining positionalinformation comprises optically determining a position of the pins. 10.A treatment plan, comprising: wearing an orthotic device designedaccording to the method of claim
 1. 11. The treatment plan of claim 10,comprising progressively wearing each of more than one orthotic(s) for aprescribed period of time.
 12. An orthotic device designed according tothe method of claim
 1. 13. The orthotic device according to claim 12,comprising a transverse ridge between the arch and the heel cup.
 14. Amethod to design an orthotic device, comprising: obtaining a digitalanatomy of a patient's foot by applying pressure in a sequential seriesto localized regions on a plantar surface of a patient's foot, whereindiffering pressures are applied to the localized regions in each step ofthe sequential series, and wherein at least one applied pressure issufficient to displace a bone in the foot to a restored bone state; anddesigning an orthotic device based on the obtained digital anatomy. 15.The method of claim 14, wherein said obtaining comprises obtaining adigital anatomy by applying pressure from a computer-controlled moveableobject to the foot.
 16. The method of claim 15, wherein said objectcomprises an array of moveable pins.
 17. The method of claim 16, whereinsaid pins are arrayed in an offset triangular grid.
 18. The method ofclaim 16, wherein the method further comprises adjusting one or morepins to obtain or analyze said digital anatomy.
 19. The method of claim18, further comprising: fabricating the orthotic device based on theadjusted pins.
 20. The method of claim 16, wherein the method furthercomprises identifying a desired pin position or pin pressure to achievethe restored bone state.
 21. The method of claim 16, wherein the methodfurther comprises fixing the position of the pins.
 22. The method ofclaim 14, wherein said digital anatomy is displayed as an image on acomputer screen.
 23. The method of claim 22, wherein said method furthercomprises simulating a movement path for moving at least one bone froman initial bone state to the restored bone state.
 24. The method ofclaim 23, wherein said movement path includes at least one intermediatestate, said at least one intermediate state being between the initialbone state and the restored bone state.
 25. The method of claim 23,wherein said movement path is, simulated by superimposition of thedigital anatomies of any two or more states and defining one or moremovements of any bone to move from an initial bone state to the restoredbone state.
 26. The method of claim 22, wherein more than one orthoticis designed based on said initial bone state and said restored bonestate.
 27. The method of claim 14, further comprising: storing thedigital anatomy on a tangible storage medium.
 28. The method of claim14, further comprising: electronically transmitting the digital anatomy.29. The method of claim 26, wherein the more than one orthotic islabeled in order of use.
 30. The method of claim 26, wherein the morethan one orthotic is delivered at one time to a patient.
 31. The methodof claim 26, wherein the more than one orthotic is deliveredsequentially to a patient.